Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-21 @ 6:36 PM
Study NCT ID:
NCT02357420
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2015-01-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000593860', 'term': 'relamorelin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 98 days', 'description': 'Safety set included all the participants who were randomized and received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 13, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Relamorelin 10 μg', 'description': 'Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 21, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Relamorelin 30 μg', 'description': 'Relamorelin 30 μg was administered SC by injection BID for 12 weeks.', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 30, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Relamorelin 100 μg', 'description': 'Relamorelin 100 μg was administered SC by injection BID for 12 weeks.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 28, 'seriousNumAtRisk': 82, 'deathsNumAffected': 1, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}], 'seriousEvents': [{'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Biliary tract disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Median nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Traumatic hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Weekly Vomiting Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.'}, {'id': 'OG001', 'title': 'Relamorelin 10 μg', 'description': 'Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.'}, {'id': 'OG002', 'title': 'Relamorelin 30 μg', 'description': 'Relamorelin 30 μg was administered SC by injection BID for 12 weeks.'}, {'id': 'OG003', 'title': 'Relamorelin 100 μg', 'description': 'Relamorelin 100 μg was administered SC by injection BID for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '17.2', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '10.3', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '5.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '7.6', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '13.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Measures mixed effects model (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.'}, {'pValue': '0.25', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.'}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.'}], 'paramType': 'MEAN', 'timeFrame': '7 days prior to Day 1 for Baseline to 7 days prior to Week 12', 'description': 'Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Each day, the participant recorded the number of vomiting episodes in the past 24 hours in the diary. Higher scores indicate more vomiting episodes. Weekly scores were averaged across the 12 weeks period. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'vomiting episodes per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). Number analyzed is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.'}, {'id': 'OG001', 'title': 'Relamorelin 10 μg', 'description': 'Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.'}, {'id': 'OG002', 'title': 'Relamorelin 30 μg', 'description': 'Relamorelin 30 μg was administered SC by injection BID for 12 weeks.'}, {'id': 'OG003', 'title': 'Relamorelin 100 μg', 'description': 'Relamorelin 100 μg was administered SC by injection BID for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.4', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '21.1', 'spread': '6.0', 'groupId': 'OG002'}, {'value': '22.3', 'spread': '6.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '-7.5', 'spread': '7.4', 'groupId': 'OG002'}, {'value': '-8.9', 'spread': '8.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days prior to Day 1 for Baseline to 7 days prior to Week 12', 'description': 'The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of DG (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Severity of nausea, bloating and abdominal pain, were assessed on a numerical rating scale of 0 to 10, with 0 equating to "no" (symptom) and 10 equating to "worst possible" (symptom). Early satiety was assessed on a 5-item scale with 1 being "Only 1 or 2 bites" and 5 being "All of a normal-sized meal"; symptom severity scores for this item were reversed and normalized to a range 0 to 10 for the development of the DGSSD 4-symptom Composite Score. The DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal pain) range is 0 to 40. Higher scores indicate worse condition. Weekly scores were averaged across 12 weeks period. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). Number analyzed is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.'}, {'id': 'OG001', 'title': 'Relamorelin 10 μg', 'description': 'Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.'}, {'id': 'OG002', 'title': 'Relamorelin 30 μg', 'description': 'Relamorelin 30 μg was administered SC by injection BID for 12 weeks.'}, {'id': 'OG003', 'title': 'Relamorelin 100 μg', 'description': 'Relamorelin 100 μg was administered SC by injection BID for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '127.1', 'spread': '36.5', 'groupId': 'OG000'}, {'value': '126.8', 'spread': '37.6', 'groupId': 'OG001'}, {'value': '128.6', 'spread': '35.9', 'groupId': 'OG002'}, {'value': '133.6', 'spread': '35.4', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '38.5', 'groupId': 'OG000'}, {'value': '-12.7', 'spread': '38.1', 'groupId': 'OG001'}, {'value': '-12.8', 'spread': '36.5', 'groupId': 'OG002'}, {'value': '-13.6', 'spread': '40.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'GE was measured via the GEBT and was reported as a time to half (t1/2) of the theoretical total GE. GEBT is a non-radioactive stable isotope breath test intended for measurement of GE of solids in participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). Number analyzed is the number of participants with data available at the given time-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.'}, {'id': 'FG001', 'title': 'Relamorelin 10 μg', 'description': 'Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.'}, {'id': 'FG002', 'title': 'Relamorelin 30 μg', 'description': 'Relamorelin 30 μg was administered SC by injection BID for 12 weeks.'}, {'id': 'FG003', 'title': 'Relamorelin 100 μg', 'description': 'Relamorelin 100 μg was administered SC by injection BID for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '109'}, {'groupId': 'FG003', 'numSubjects': '82'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '109'}, {'comment': '1 participant from safety set did not enter FAS.', 'groupId': 'FG003', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '3 participants who discontinued prematurely were included in completed as they fulfilled Visit 8.', 'groupId': 'FG000', 'numSubjects': '92'}, {'comment': '1 participant who discontinued prematurely was included in completed as he/she fulfilled Visit 8.', 'groupId': 'FG001', 'numSubjects': '86'}, {'comment': '1 participant who discontinued prematurely was included in completed as he/she fulfilled Visit 8.', 'groupId': 'FG002', 'numSubjects': '93'}, {'groupId': 'FG003', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Prohibited Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawn Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total 393 participants were randomized and received study treatment, and 334 participants completed the study. Five participants who received study drug but discontinued prematurely were summarized as completing the study because they fulfilled the Visit 8 (Week 12) assessments as per protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '393', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.'}, {'id': 'BG001', 'title': 'Relamorelin 10 μg', 'description': 'Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.'}, {'id': 'BG002', 'title': 'Relamorelin 30 μg', 'description': 'Relamorelin 30 μg was administered SC by injection BID for 12 weeks.'}, {'id': 'BG003', 'title': 'Relamorelin 100 μg', 'description': 'Relamorelin 100 μg was administered SC by injection BID for 12 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '56.0', 'spread': '11.7', 'groupId': 'BG002'}, {'value': '57.1', 'spread': '11.0', 'groupId': 'BG003'}, {'value': '57.0', 'spread': '11.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '245', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '148', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Set (SS) included all participants who were randomized and received at least 1 dose of study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 393}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'dispFirstSubmitDate': '2016-02-16', 'completionDateStruct': {'date': '2016-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-01', 'studyFirstSubmitDate': '2015-01-29', 'dispFirstSubmitQcDate': '2016-02-16', 'resultsFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2015-02-05', 'dispFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-01', 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Weekly Vomiting Episodes', 'timeFrame': '7 days prior to Day 1 for Baseline to 7 days prior to Week 12', 'description': 'Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Each day, the participant recorded the number of vomiting episodes in the past 24 hours in the diary. Higher scores indicate more vomiting episodes. Weekly scores were averaged across the 12 weeks period. A negative change from Baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)', 'timeFrame': '7 days prior to Day 1 for Baseline to 7 days prior to Week 12', 'description': 'The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of DG (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Severity of nausea, bloating and abdominal pain, were assessed on a numerical rating scale of 0 to 10, with 0 equating to "no" (symptom) and 10 equating to "worst possible" (symptom). Early satiety was assessed on a 5-item scale with 1 being "Only 1 or 2 bites" and 5 being "All of a normal-sized meal"; symptom severity scores for this item were reversed and normalized to a range 0 to 10 for the development of the DGSSD 4-symptom Composite Score. The DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal pain) range is 0 to 40. Higher scores indicate worse condition. Weekly scores were averaged across 12 weeks period. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'GE was measured via the GEBT and was reported as a time to half (t1/2) of the theoretical total GE. GEBT is a non-radioactive stable isotope breath test intended for measurement of GE of solids in participants. A negative change from Baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Delayed Gastric Emptying', 'Vomiting', 'Gastroparesis', 'Gastrointestinal Motility Disorder'], 'conditions': ['Diabetes Mellitus', 'Diabetes Mellitus Complications', 'Gastroparesis']}, 'referencesModule': {'references': [{'pmid': '32301137', 'type': 'DERIVED', 'citation': 'Camilleri M, Lembo A, McCallum R, Tourkodimitris S, Kemps L, Miller MB, Bertelsen K, Iacob A. Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data. Aliment Pharmacol Ther. 2020 Jun;51(11):1139-1148. doi: 10.1111/apt.15711. Epub 2020 Apr 17.'}, {'pmid': '28760384', 'type': 'DERIVED', 'citation': 'Camilleri M, McCallum RW, Tack J, Spence SC, Gottesdiener K, Fiedorek FT. Efficacy and Safety of Relamorelin in Diabetics With Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study. Gastroenterology. 2017 Nov;153(5):1240-1250.e2. doi: 10.1053/j.gastro.2017.07.035. Epub 2017 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1 and Type 2 diabetes mellitus and gastroparesis. Study drug (relamorelin and placebo) will be administered subcutaneously in a blinded fashion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) with stable glycemic control and Hemoglobin A1c (HbA1c) ≤11% at screening.\n* Diabetic gastroparesis (DG), defined as at least a 3-month history of symptoms suggestive of gastroparesis on an ongoing basis (e.g., vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain).\n* Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) score ≥2.6 at least once during the Screening Period (Visits 1-2).\n* At least 2 vomiting episodes during the \\~2 weeks prior to the first screening visit (Visit 1), as ascertained by patient history.\n* Delayed Gastric Emptying (GE) confirmed at screening by abnormal Gastric Emptying Breath Test (GEBT), defined as GE half-time (t1/2) ≥79 minutes (the 80th percentile of normative data). At least 50% of patients enrolled will have a t1/2 ≥97 minutes (i.e., the 95th percentile).\n* Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to Visit 2 (daily adjustments of insulin doses are permitted).\n* No use of metoclopramide, erythromycin, domperidone, or other gastrointestinal (GI) motility agents, or anti-emetics for at least 2 weeks prior to Visit 2, and willingness to remain off these medications (except as used as part of protocol-specific rescue medication) during the course of the clinical trial.\n* Body mass index \\>18 kg/m2.\n* If female, has a negative serum or urine pregnancy test and is not lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female patients unable to bear children must have this documented in the electronic case report form (eCRF) (i.e., tubal ligation, hysterectomy, or post-menopausal \\[defined as a minimum of 1 year since the last menstrual period\\]). Post-menopausal status will be confirmed by measurement of follicle stimulating hormone (FSH).\n* Able to provide written informed consent prior to any study procedures and willing and able to comply with study procedures.\n\nAdditional inclusion criteria for randomization after the 2-week single-blind placebo run-in period:\n\n* Compliance with the completion of the Diabetic Gastroparesis Symptom Severity Diary (DGSSD) and study drug injections, defined as approximately 80% diary completions and approximately 80% administration of injections, during the 2-week single-blind placebo run-in period. For those patients whose compliance is measured to be \\<80%, the final decision to randomize a patient will be made by the Investigator and the Sponsor (or designee).\n* At least one vomiting episode at any time during the 2-week single-blind placebo run-in period, as recorded in the DGSSD.\n\nExclusion Criteria:\n\n* Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube \\[e.g., Percutaneous Endoscopic Gastrostomy (PEG) tube\\] for feeding or decompression.\n* History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure. (A history of diagnostic endoscopy is not exclusionary.)\n* History of pyloric injection of botulinum toxin within 6 months of screening.\n* Patients with clinical suspicion of upper GI obstruction (e.g., peptic stricture) must have been evaluated per standard of care and obstruction ruled out before screening.\n* Currently taking opiates, or expecting to use opiates during the course of the clinical trial.\n* Currently taking Glucagon-like peptide-1 (GLP-1) agonists, Sodium-glucose co-transporter 2 (SGLT2) inhibitors or pramlintide.\n* Allergic or intolerant of egg, wheat, milk, or algae, as these are components of the Gastric emptying breath test (GEBT) study meal. (Gluten-free crackers can be provided.)\n* History of anorexia nervosa, binge-eating, or bulimia within 5 years of screening.\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 × upper limit of normal (ULN) at Visit 1.\n* History of intestinal malabsorption or pancreatic exocrine disease.\n* Requires hemodialysis or has end-stage renal disease.\n* History of human immunodeficiency virus (HIV) infection.\n* Clinically significant neurologic or psychiatric disorders that are likely to impact compliance with protocol requirements.\n* Poor venous access or inability to tolerate venipuncture.\n* Participation in a clinical study within the 30 days prior to dosing in the present study.\n* Any other reason that, in the Investigator's opinion, would confound proper interpretation of the study or expose a patient to unacceptable risk, including renal, hepatic or cardiopulmonary disease, or significant acute electrocardiogram (ECG) abnormalities."}, 'identificationModule': {'nctId': 'NCT02357420', 'briefTitle': 'Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis', 'orgStudyIdInfo': {'id': 'RM-131-009'}, 'secondaryIdInfos': [{'id': '2014-005623-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Relamorelin 10 μg', 'description': 'Relamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.', 'interventionNames': ['Drug: Relamorelin']}, {'type': 'EXPERIMENTAL', 'label': 'Relamorelin 30 μg', 'description': 'Relamorelin 30 μg was administered SC by injection BID for 12 weeks.', 'interventionNames': ['Drug: Relamorelin']}, {'type': 'EXPERIMENTAL', 'label': 'Relamorelin 100 μg', 'description': 'Relamorelin 100 μg was administered SC by injection BID for 12 weeks.', 'interventionNames': ['Drug: Relamorelin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo-matching relamorelin was administered SC by injection BID for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Relamorelin', 'type': 'DRUG', 'otherNames': ['RM-131'], 'description': 'Double blind relamorelin was given subcutaneously BID for 12 weeks.', 'armGroupLabels': ['Relamorelin 10 μg', 'Relamorelin 100 μg', 'Relamorelin 30 μg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo given subcutaneously for 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Digestive Health Specialist of the 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