Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT01265550
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2010-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018662', 'term': 'Fundoplication'}, {'id': 'D001418', 'term': 'Baclofen'}, {'id': 'D003891', 'term': 'Desipramine'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sjspechler@aol.com', 'title': 'Stuart Spechler', 'organization': 'Dallas VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From consent to subject termination, up to 14 months.', 'description': 'Events reported in the all enrolled column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.', 'eventGroups': [{'id': 'EG000', 'title': 'Medical Treatment Group', 'description': 'baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 18, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 17, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo Medical Treatment Group', 'description': 'baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 18, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'All Enrolled', 'description': 'All patients consented.', 'otherNumAtRisk': 366, 'deathsNumAtRisk': 288, 'otherNumAffected': 79, 'seriousNumAtRisk': 366, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Faeces hard', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Faeces soft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cyclic vomiting syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedural discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Plantar fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 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'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Violence-related symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Temporal arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Success; ≥50% improvement in the baseline GERD-HRQL score at 12 months.\n\nFailure; \\<50% improvement in the baseline GERD-HRQL score at 12 months or:\n\n1. For patients randomized to Surgical Treatment: a.\\<50% improvement in the baseline GERD-HRQL score and/or persistent heartburn of sufficient severity to warrant treatment with any antisecretory medication, antireflux medication or neurotropic medication at any quarterly clinic visit.\n2. For patients randomized to Active Medical or Placebo Medical Treatment:\n\n a.inability to tolerate both study medications or b.For patients treated with desipramine, i.\\<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with the second drug at any quarterly clinic visit. c.For patients in whom desipramine is contraindicated,i.\\<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with baclofen or its corresponding placebo at any quarterly clinic visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Esophageal Ulceration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for esophageal ulceration.'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Reflux Esophagus.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for reflux esophagus.'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Eosinophilic Esophagitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for eosinophilic esophagitis'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Active Ulceration of the Stomach and/or Duodenum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for active ulcerations of the stomach and/or duodenum'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Neoplasm of the Esophagus, Stomach or Duodenum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for neoplasm of the esophagus, stomach or duodenum'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Candida Esophagitis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for candida esophagitis'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Gastric Outlet Obstruction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for gastric outlet obstruction'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Achalasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for achalasia'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Aperistalsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for aperistalsis'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Distal Esophageal Spasm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for distal esophageal spasm'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Nutcracker Esophagus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for nutcracker esophagus'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Ineffective Esophageal Motility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for ineffective esophageal motility'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Rapid Contraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for rapid contraction'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Hypertensive Peristalsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for hypertensive peristalsis'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Jackhammer Esophagus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for jackhammer esophagus'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Weak Peristalsis I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for weak peristalsis I'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Weak Peristalsis II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for weak peristalsis II'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Anxiety and/or Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for anxiety and/or depression'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Functional Heartburn', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional heartburn'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Functional Chest Pain of Presumed Esophageal Origin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional chest pain of presumed esophageal origin'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Functional Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional dysphagia'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Globus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for globus'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Belching Disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for belching disorders'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Chronic Idiopathic Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for chronic idiopathic nausea'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Functional Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional vomiting'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Cyclic Vomiting Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for cyclic vomiting syndrome'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Irritable Bowel Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for irritable bowel syndrome'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Functional Bloating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional bloating'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Functional Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional diarrhea'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Unspecified Functional Bowel Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for unspecified functional bowel disorder'}, {'type': 'SECONDARY', 'title': 'Number of Enrolled Participants With Functional Gallbladder Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional gallbladder disorder'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Anxiety and/or Depression.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Association between anxiety and/or depression (GAD-7 and PHQ-9) and the outcome of medical and surgical treatments (success or failure) will be evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Functional Heartburn', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of functional heartburn as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Functional Chest Pain of Presumed Esophageal Origin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of functional chest pain of presumed esophageal origin as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Functional Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of functional dysphagia as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Globus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of globus as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Belching Disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of belching disorders as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Chronic Idiopathic Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of chronic idiopathic nausea as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Functional Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of functional vomiting as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Cyclic Vomiting Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of cyclic vomiting syndrome as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Irritable Bowel Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of irritable bowel syndrome as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Functional Bloating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of functional bloating as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Functional Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of functional diarrhea as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Unspecified Functional Bowel Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of unspecified functional bowel disorder as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Participants With Functional Gallbladder Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Treatment Group', 'description': 'Omeprazole + baclofen or Omeprazole + desipramine\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'OG001', 'title': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications\n\nNissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'OG002', 'title': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo\n\nbaclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Presence of functional gallbladder disorder as assessed by the ROME III functional GI disorders questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treatment successes'}, {'type': 'SECONDARY', 'title': 'Number of Successful Surgery Participants With Dissection of Distal Esophagus to Obtain at Least 2.5cm of Tension-free, Intra-abdominal Esophagus Performed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Surgery Participants With Complete Mobilization of the Fundus, to Include All Short Gastric and Posterior Gastric Vessels to the Base of the Left Crus Performed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Surgery Participants With Closure of the Crura With Non-absorbable Suture to be Snug With a Dilator of at Least 56 French Diameter Performed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Surgery Participants With Passage of an Esophageal Dilator of at Least 56 French Diameter Performed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Surgery Participants With Fundoplication Between 1.5 and 2.5cm in Length Performed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Surgery Participants With Fundoplication Placed Above the Epiphrenic Fat Pad, Using 3 Sutures Performed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Surgery Participants With Fundoplication Secured to Esophagus With at Least Two Sutures Performed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Surgery Participants With Fundoplication Floppiness Demonstrated by Passing a Grasper Between Fundoplication and Dilator-filled Esophagus Performed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Medical Treatment Group', 'description': 'baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'FG001', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'FG002', 'title': 'Placebo Medical Treatment Group', 'description': 'baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'FG003', 'title': 'All Enrolled', 'description': 'All patients consented.'}], 'periods': [{'title': 'Pre Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '366'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '288'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '70'}]}, {'type': 'Technical Exclusions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'GERD, PPI-Responsive', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'Non-GERD organic disorders', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'Functional heartburn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '99'}]}]}, {'title': 'Post Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '288', 'groupId': 'BG003'}, {'value': '366', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Medical Treatment Group', 'description': 'baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'BG001', 'title': 'Surgical Treatment Group', 'description': 'Nissen fundoplication: laparoscopic antireflux surgery'}, {'id': 'BG002', 'title': 'Placebo Medical Treatment Group', 'description': 'baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.\n\nDesipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.'}, {'id': 'BG003', 'title': 'Not Randomized', 'description': 'Subset of all enrolled participants who did not end up being randomized to the study.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '280', 'groupId': 'BG003'}, {'value': '358', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '43.9', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '44.9', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '11.7', 'groupId': 'BG002'}, {'value': '49.3', 'spread': '12.2', 'groupId': 'BG003'}, {'value': '45.4', 'spread': '11.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}, {'value': '357', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '216', 'groupId': 'BG003'}, {'value': '280', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}, {'value': '357', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}, {'value': '294', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}, {'value': '357', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '183', 'groupId': 'BG003'}, {'value': '237', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Partial Double Blind (Medical Treatment Groups)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 366}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-17', 'studyFirstSubmitDate': '2010-12-21', 'resultsFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2010-12-22', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-22', 'studyFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months', 'timeFrame': '12 months', 'description': 'Success; ≥50% improvement in the baseline GERD-HRQL score at 12 months.\n\nFailure; \\<50% improvement in the baseline GERD-HRQL score at 12 months or:\n\n1. For patients randomized to Surgical Treatment: a.\\<50% improvement in the baseline GERD-HRQL score and/or persistent heartburn of sufficient severity to warrant treatment with any antisecretory medication, antireflux medication or neurotropic medication at any quarterly clinic visit.\n2. For patients randomized to Active Medical or Placebo Medical Treatment:\n\n a.inability to tolerate both study medications or b.For patients treated with desipramine, i.\\<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with the second drug at any quarterly clinic visit. c.For patients in whom desipramine is contraindicated,i.\\<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with baclofen or its corresponding placebo at any quarterly clinic visit.'}], 'secondaryOutcomes': [{'measure': 'Number of Enrolled Participants With Esophageal Ulceration.', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Reflux Esophagus.', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Eosinophilic Esophagitis', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Active Ulceration of the Stomach and/or Duodenum.', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Neoplasm of the Esophagus, Stomach or Duodenum', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Candida Esophagitis.', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Gastric Outlet Obstruction', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Achalasia', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Aperistalsis', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Distal Esophageal Spasm', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Nutcracker Esophagus', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Ineffective Esophageal Motility', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Rapid Contraction', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Hypertensive Peristalsis', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Jackhammer Esophagus', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Weak Peristalsis I', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Weak Peristalsis II', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Anxiety and/or Depression', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Functional Heartburn', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Functional Chest Pain of Presumed Esophageal Origin', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Functional Dysphagia', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Globus', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Belching Disorders', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Chronic Idiopathic Nausea', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Functional Vomiting', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Cyclic Vomiting Syndrome', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Irritable Bowel Syndrome', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Functional Bloating', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Functional Diarrhea', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Unspecified Functional Bowel Disorder', 'timeFrame': 'Screening'}, {'measure': 'Number of Enrolled Participants With Functional Gallbladder Disorder', 'timeFrame': 'Screening'}, {'measure': 'Number of Successful Participants With Anxiety and/or Depression.', 'timeFrame': '12 months', 'description': 'Association between anxiety and/or depression (GAD-7 and PHQ-9) and the outcome of medical and surgical treatments (success or failure) will be evaluated.'}, {'measure': 'Number of Successful Participants With Functional Heartburn', 'timeFrame': '12 months', 'description': 'Presence of functional heartburn as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Functional Chest Pain of Presumed Esophageal Origin', 'timeFrame': '12 months', 'description': 'Presence of functional chest pain of presumed esophageal origin as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Functional Dysphagia', 'timeFrame': '12 months', 'description': 'Presence of functional dysphagia as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Globus', 'timeFrame': '12 months', 'description': 'Presence of globus as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Belching Disorders', 'timeFrame': '12 months', 'description': 'Presence of belching disorders as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Chronic Idiopathic Nausea', 'timeFrame': '12 months', 'description': 'Presence of chronic idiopathic nausea as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Functional Vomiting', 'timeFrame': '12 months', 'description': 'Presence of functional vomiting as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Cyclic Vomiting Syndrome', 'timeFrame': '12 months', 'description': 'Presence of cyclic vomiting syndrome as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Irritable Bowel Syndrome', 'timeFrame': '12 months', 'description': 'Presence of irritable bowel syndrome as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Functional Bloating', 'timeFrame': '12 months', 'description': 'Presence of functional bloating as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Functional Diarrhea', 'timeFrame': '12 months', 'description': 'Presence of functional diarrhea as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Unspecified Functional Bowel Disorder', 'timeFrame': '12 months', 'description': 'Presence of unspecified functional bowel disorder as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Participants With Functional Gallbladder Disorder', 'timeFrame': '12 months', 'description': 'Presence of functional gallbladder disorder as assessed by the ROME III functional GI disorders questionnaire.'}, {'measure': 'Number of Successful Surgery Participants With Dissection of Distal Esophagus to Obtain at Least 2.5cm of Tension-free, Intra-abdominal Esophagus Performed.', 'timeFrame': '12 months'}, {'measure': 'Number of Successful Surgery Participants With Complete Mobilization of the Fundus, to Include All Short Gastric and Posterior Gastric Vessels to the Base of the Left Crus Performed.', 'timeFrame': '12 months'}, {'measure': 'Number of Successful Surgery Participants With Closure of the Crura With Non-absorbable Suture to be Snug With a Dilator of at Least 56 French Diameter Performed.', 'timeFrame': '12 months'}, {'measure': 'Number of Successful Surgery Participants With Passage of an Esophageal Dilator of at Least 56 French Diameter Performed.', 'timeFrame': '12 months'}, {'measure': 'Number of Successful Surgery Participants With Fundoplication Between 1.5 and 2.5cm in Length Performed.', 'timeFrame': '12 months'}, {'measure': 'Number of Successful Surgery Participants With Fundoplication Placed Above the Epiphrenic Fat Pad, Using 3 Sutures Performed.', 'timeFrame': '12 months'}, {'measure': 'Number of Successful Surgery Participants With Fundoplication Secured to Esophagus With at Least Two Sutures Performed.', 'timeFrame': '12 months'}, {'measure': 'Number of Successful Surgery Participants With Fundoplication Floppiness Demonstrated by Passing a Grasper Between Fundoplication and Dilator-filled Esophagus Performed.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['GERD']}, 'referencesModule': {'references': [{'pmid': '31618539', 'type': 'DERIVED', 'citation': 'Spechler SJ, Hunter JG, Jones KM, Lee R, Smith BR, Mashimo H, Sanchez VM, Dunbar KB, Pham TH, Murthy UK, Kim T, Jackson CS, Wallen JM, von Rosenvinge EC, Pearl JP, Laine L, Kim AW, Kaz AM, Tatum RP, Gellad ZF, Lagoo-Deenadayalan S, Rubenstein JH, Ghaferi AA, Lo WK, Fernando RS, Chan BS, Paski SC, Provenzale D, Castell DO, Lieberman D, Souza RF, Chey WD, Warren SR, Davis-Karim A, Melton SD, Genta RM, Serpi T, Biswas K, Huang GD. Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn. N Engl J Med. 2019 Oct 17;381(16):1513-1523. doi: 10.1056/NEJMoa1811424.'}]}, 'descriptionModule': {'briefSummary': 'Background: Gastroesophageal reflux disease (GERD), which affects at least 20% of adult Americans, may be especially common and severe in Veteran patients. Proton pump inhibitors (PPIs), which block gastric acid production, are the most effective medications for GERD, and the VA spends more than $177 million each year on outpatient PPI prescriptions. PPIs do not prevent the reflux of non-acidic material and do not completely eliminate esophageal acid exposure, however, and bothersome GERD symptoms persist in approximately 40% of patients treated with PPIs. Recent studies using the new technique of esophageal pH/ impedance monitoring, which detects the reflux of both acidic and non-acidic materials, have shown that PPI-resistant GERD symptoms correlate with episodes of reflux (acidic and/or non-acidic) in approximately one-half of patients. For those patients, an antireflux operation might relieve symptoms and obviate the expense of ineffective PPI therapy, but the efficacy of modern, laparoscopic fundoplication in this regard is not clear. For patients with PPI-resistant GERD symptoms, furthermore, the efficacy of medications that that can prevent gastroesophageal reflux (e.g. baclofen) or diminish pain of esophageal origin (e.g. neurotropic agents like desipramine) also is not clear. Study Hypothesis: Laparoscopic antireflux surgery (Nissen fundoplication) is superior to medical therapy (PPIs plus baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring.\n\nStudy Goals: The primary goal is to compare the efficacy of laparoscopic Nissen fundoplication and medical therapy (PPIs plus baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring, and to compare the efficacy of each therapy with placebo. Secondary goals are: 1) To determine the frequency with which non-GERD disorders underlie "PPI failure," 2) To determine the frequency of functional gastrointestinal symptoms, anxiety and depression in patients who have persistent heartburn while on PPIs, 3) To determine whether functional gastrointestinal symptoms, anxiety and depression is associated with the outcomes of medical and surgical therapies, and 4) To determine whether the outcome of Nissen fundoplication is associated with adherence to technical aspects of the operation.\n\nStudy Design: Up to 16 VA medical centers, there will be a 30-month recruitment period to enroll 108 patients with heartburn that is refractory to PPI therapy. Patients will have their baseline GERD symptoms scored using the GERD Health-Related Quality of Life (GERD-HRQL) index, and will have endoscopy, esophageal manometry and esophageal pH/impedance monitoring while on PPI therapy. Patients who have episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring will be randomized to one of three treatment groups: Surgical Treatment (laparoscopic Nissen fundoplication), Active Medical Treatment (omeprazole and baclofen initially; desipramine for baclofen failures) or Placebo Medical Treatment (omeprazole, placebo baclofen, placebo desipramine). All patients will have quarterly clinic visits for symptom scoring and laboratory testing. At one year, patients will have a final symptom scoring and repeat endoscopy, esophageal manometry and esophageal pH/impedance monitoring. Treatment success will be defined as 50% improvement in the GERD-HRQL score at 12 months. Patients also will complete the Hospital Anxiety and Depression Scale (HADS), Rome III Functional GI Disorders Questionnaire and the Short-Form Health Survey (SF-36) at baseline and one year. The results will be correlated with treatment outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years\n* History of heartburn (defined as a burning sensation in the retrosternal area of the chest) that is refractory to antisecretory medications\n* Initial GERD-HRQL:\n\n * Total score must be at least 6 and at least one of the six heartburn questions must be scored at least 2\n* GERD-HRQL after two weeks of treatment with omeprazole:\n\n * Total score must be \\>50% of the initial GERD-HRQL score and at least one of the six heartburn questions must be scored at least 2\n* Either or both of the following by baseline esophageal pH/multichannel intraluminal impedance (MII) monitoring in patients on omeprazole 20 mg two times a day (BID):\n\n * Positive symptom association probability (SAP) (\\>95%) for acid reflux, non-acid reflux or all reflux.\n * Abnormal acid reflux (esophageal pH\\<4 for at least 4.2% of the 24-hour monitoring period)\n\nExclusion Criteria:\n\n* Patients who do not have heartburn, defined as a burning sensation in the chest\n* Patients unwilling or unable to provide informed consent\n* Pregnancy or women unwilling to use effective contraception\n* Age \\<18 or \\>70 years\n* History of surgery on the stomach or esophagus\n* History of seizure disorder\n* History of heart block\n* Allergy to or previous inability to tolerate study medications (omeprazole, baclofen, desipramine)\n* Esophageal varices\n* Cirrhosis\n* Co-morbidity of sufficient severity to preclude elective surgery (e.g. pulmonary, cardiac, renal, liver disease)\n* History of disorders that can cause medically-refractory "GERD symptoms" (eosinophilic esophagitis, neoplasms of the upper gastrointestinal tract, gastroparesis, achalasia)\n* Myocardial infarction within the past 6 months\n* History of schizophrenia\n* Current use of clopidogrel\n* Patients who have a contraindication to omeprazole or baclofen or who require therapy with a medication that has a clinically important drug interaction with omeprazole or baclofen.\n* Patients who, in the judgment of the PI, are not suitable candidates for therapy with a study medication (omeprazole, baclofen, desipramine)\n* Initial GERD-HRQL score: Total score \\<6 and/or all heartburn scores \\<2\n* Inability to tolerate omeprazole during the 2-week treatment phase (before randomization)\n* GERD-HRQL after two weeks of treatment with omeprazole: Total score less than or equal to 50% of initial GERD-HRQL score and/or all heartburn scores \\<2\n* Laboratory abnormalities including:\n\n * Platelet count \\<100,000\n * international normalized ratio (INR) \\>1.5 (off anticoagulants)\n * Serum creatinine \\>2.0 mg per deciliter\n* Endoscopic abnormalities including:\n\n * Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis\n * Active ulceration of the esophagus that is not due to reflux esophagitis\n * Candida esophagitis\n * Esophageal varices\n * Active ulceration of the stomach and/or duodenum\n * Neoplasm of the esophagus, stomach or duodenum\n * Gastric outlet obstruction\n * Eosinophilic esophagitis at least (15 eosinophils per high power field in any esophageal biopsy specimen)\n* Manometric abnormalities including:\n\n * Achalasia\n * Complete aperistalsis\n* Negative SAP ( 95%) for acid reflux, non-acid reflux and all reflux on baseline combined esophageal pH/MII monitoring and normal acid reflux (esophageal pH\\<4 for \\<4.2% of the 24-hour monitoring period)\n* Study surgeon identifies a contraindication to laparoscopic Nissen fundoplication\n* Morbid obesity (BMI at least 40)\n* Large paraesophageal hernia'}, 'identificationModule': {'nctId': 'NCT01265550', 'briefTitle': 'A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'CSP #573 - A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors', 'orgStudyIdInfo': {'id': '573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Medical Treatment Group', 'description': 'Omeprazole or Omeprazole + baclofen or Omeprazole + desipramine', 'interventionNames': ['Drug: baclofen', 'Drug: Desipramine']}, {'type': 'OTHER', 'label': 'Surgical Treatment Group', 'description': 'Laparoscopic nissen fundoplications', 'interventionNames': ['Device: Nissen fundoplication']}, {'type': 'OTHER', 'label': 'Placebo Medical Treatment Group', 'description': 'Omeprazole + placebo', 'interventionNames': ['Drug: baclofen', 'Drug: Desipramine']}], 'interventions': [{'name': 'Nissen fundoplication', 'type': 'DEVICE', 'description': 'laparoscopic antireflux surgery', 'armGroupLabels': ['Surgical Treatment Group']}, {'name': 'baclofen', 'type': 'DRUG', 'description': 'Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.\n\nThe dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.', 'armGroupLabels': ['Medical Treatment Group', 'Placebo Medical Treatment Group']}, {'name': 'Desipramine', 'type': 'DRUG', 'description': 'Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.', 'armGroupLabels': ['Medical Treatment Group', 'Placebo Medical Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham VA Medical Center, Birmingham, AL', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southern Arizona VA Health Care System, Tucson, AZ', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92357', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'VA Loma Linda Healthcare System, Loma Linda, CA', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Long Beach Healthcare System, Long Beach, CA', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healthcare System West Haven Campus, West Haven, CT', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System, Ann Arbor, MI', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City VA Medical Center, Kansas City, MO', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Syracuse VA Medical Center, Syracuse, NY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Stuart J Spechler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}