Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT00464308
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2007-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D006356', 'term': 'Heartburn'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D064750', 'term': 'Rabeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mhandel@its.jnj.com', 'phone': '+61 2 9815 3219', 'title': 'Executive Director, Medical & Scientific Affairs', 'organization': 'Janssen-Cilag Pty Ltd'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The MCID of 7.5% was amended to 9% to maintain power with smaller sample size.The proportion of patients without heartburn symptoms at baseline was not evenly distributed between treatment arms. This was a significant predictor of symptom resolution.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rabeprazole 20 mg/Day', 'description': 'Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily', 'otherNumAtRisk': 464, 'otherNumAffected': 151, 'seriousNumAtRisk': 464, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Esomeprazole 40 mg/Day', 'description': 'Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily', 'otherNumAtRisk': 469, 'otherNumAffected': 155, 'seriousNumAtRisk': 469, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Esomeprazole 20 mg/Day', 'description': 'Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily', 'otherNumAtRisk': 459, 'otherNumAffected': 158, 'seriousNumAtRisk': 459, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Gastrointestinal motility and defaecation cond', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 40, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 86, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 80, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 77, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Salivary gland conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infections - pathogen class unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral infectious disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal and connective tissue disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 32, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neurological disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'meniscal tear of right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'alleged assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'perianal abscess drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'multiple pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Patients With Complete Resolution of Heartburn by Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rabeprazole 20 mg/Day', 'description': 'Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG001', 'title': 'Esomeprazole 40 mg/Day', 'description': 'Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG002', 'title': 'Esomeprazole 20 mg/Day', 'description': 'Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}], 'classes': [{'categories': [{'measurements': [{'value': '272', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion difference', 'ciPctValue': '95', 'paramValue': '-0.11', 'pValueComment': 'Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.', 'estimateComment': 'Assumed that the true resolution rates in the rab20 and eso40 groups would be 30% (0.3). Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%', 'groupDescription': 'Primary endpoints were assessed using non-inferiority tests. See below.', 'statisticalMethod': 'Non-inferiority', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4'}], 'paramType': 'NUMBER', 'timeFrame': 'week 4 of treatment', 'description': 'Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population was used for all efficacy analyses. The data were reanalysed using the compliance population (defined as all subjects who consumed at least 80% of study medication and who completed at least 80% of data recording).'}, {'type': 'SECONDARY', 'title': 'The Median Time to Complete Resolution of Heartburn Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rabeprazole 20 mg/Day', 'description': 'Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG001', 'title': 'Esomeprazole 40 mg/Day', 'description': 'Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG002', 'title': 'Esomeprazole 20 mg/Day', 'description': 'Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '15'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'week 4 of treatment', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'The Median Time to Complete Relief of Regurgitation Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rabeprazole 20 mg/Day', 'description': 'Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG001', 'title': 'Esomeprazole 40 mg/Day', 'description': 'Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG002', 'title': 'Esomeprazole 20 mg/Day', 'description': 'Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '12'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '14'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rabeprazole 20 mg/Day', 'description': 'Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG001', 'title': 'Esomeprazole 40 mg/Day', 'description': 'Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG002', 'title': 'Esomeprazole 20 mg/Day', 'description': 'Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}], 'classes': [{'categories': [{'measurements': [{'value': '281', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion difference', 'ciPctValue': '95', 'paramValue': '-0.051', 'pValueComment': 'All statistical tests were interpreted at the 5% significance level (2-tailed).', 'estimateComment': 'Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%', 'groupDescription': 'Primary endpoints were assessed using non-inferiority tests. See below.', 'statisticalMethod': 'non-inferiority', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rabeprazole 20 mg/Day', 'description': 'Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG001', 'title': 'Esomeprazole 40 mg/Day', 'description': 'Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG002', 'title': 'Esomeprazole 20 mg/Day', 'description': 'Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}], 'classes': [{'categories': [{'measurements': [{'value': '405', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '414', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion difference', 'ciPctValue': '95', 'paramValue': '-0.053', 'pValueComment': 'Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.', 'estimateComment': 'Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%', 'groupDescription': 'Primary endpoints were assessed using non-inferiority tests. See below.', 'statisticalMethod': 'non-inferiority', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': "Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Symptom scores 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe'}, {'type': 'PRIMARY', 'title': 'The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rabeprazole 20 mg/Day', 'description': 'Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG001', 'title': 'Esomeprazole 40 mg/Day', 'description': 'Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG002', 'title': 'Esomeprazole 20 mg/Day', 'description': 'Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}], 'classes': [{'categories': [{'measurements': [{'value': '397', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion difference', 'ciPctValue': '95', 'paramValue': '-0.061', 'pValueComment': 'Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.', 'estimateComment': 'Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%', 'groupDescription': 'Primary endpoints were assessed using non-inferiority tests. See below.', 'statisticalMethod': 'non-inferiority', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': "Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rabeprazole 20 mg/Day', 'description': 'Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG001', 'title': 'Esomeprazole 40 mg/Day', 'description': 'Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'OG002', 'title': 'Esomeprazole 20 mg/Day', 'description': 'Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}], 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000', 'lowerLimit': '53.1', 'upperLimit': '59.5'}, {'value': '63.4', 'groupId': 'OG001', 'lowerLimit': '60.2', 'upperLimit': '66.6'}, {'value': '56.1', 'groupId': 'OG002', 'lowerLimit': '52.9', 'upperLimit': '59.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rabeprazole 20 mg/Day', 'description': 'Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'FG001', 'title': 'Esomeprazole 40 mg/Day', 'description': 'Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'FG002', 'title': 'Esomeprazole 20 mg/Day', 'description': 'Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '464'}, {'groupId': 'FG001', 'numSubjects': '469'}, {'groupId': 'FG002', 'numSubjects': '459'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}, {'groupId': 'FG001', 'numSubjects': '406'}, {'groupId': 'FG002', 'numSubjects': '400'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Patient discontinued and other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'BG000'}, {'value': '469', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}, {'value': '1392', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Rabeprazole 20 mg/Day', 'description': 'Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'BG001', 'title': 'Esomeprazole 40 mg/Day', 'description': 'Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'BG002', 'title': 'Esomeprazole 20 mg/Day', 'description': 'Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '48', 'spread': '14.7', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '14.8', 'groupId': 'BG002'}, {'value': '46.7', 'spread': '14.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}, {'value': '620', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '772', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '464', 'groupId': 'BG000'}, {'value': '469', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}, {'value': '1392', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1392}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2007-04-20', 'resultsFirstSubmitDate': '2009-06-09', 'studyFirstSubmitQcDate': '2007-04-20', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-26', 'studyFirstPostDateStruct': {'date': '2007-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Patients With Complete Resolution of Heartburn by Week 4', 'timeFrame': 'week 4 of treatment', 'description': 'Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.'}, {'measure': 'The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4', 'timeFrame': '4 weeks', 'description': 'Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.'}, {'measure': 'The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4', 'timeFrame': '4 weeks', 'description': "Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe."}, {'measure': 'The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4', 'timeFrame': '4 weeks', 'description': "Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe."}], 'secondaryOutcomes': [{'measure': 'The Median Time to Complete Resolution of Heartburn Symptoms.', 'timeFrame': 'week 4 of treatment'}, {'measure': 'The Median Time to Complete Relief of Regurgitation Symptoms', 'timeFrame': '4 weeks'}, {'measure': 'The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastroesophageal Reflux', 'Heartburn', 'Proton pump inhibitor', 'GORD'], 'conditions': ['Gastro-oesophageal Reflux']}, 'referencesModule': {'references': [{'pmid': '21317257', 'type': 'DERIVED', 'citation': 'Biscola FT, Abe CM, Guth BE. Determination of adhesin gene sequences in, and biofilm formation by, O157 and non-O157 Shiga toxin-producing Escherichia coli strains isolated from different sources. Appl Environ Microbiol. 2011 Apr;77(7):2201-8. doi: 10.1128/AEM.01920-10. Epub 2011 Feb 11.'}, {'pmid': '19210493', 'type': 'DERIVED', 'citation': 'Eggleston A, Katelaris PH, Nandurkar S, Thorpe P, Holtmann G; Treat Study Group. Clinical trial: the treatment of gastro-oesophageal reflux disease in primary care--prospective randomized comparison of rabeprazole 20 mg with esomeprazole 20 and 40 mg. Aliment Pharmacol Ther. 2009 May 1;29(9):967-78. doi: 10.1111/j.1365-2036.2009.03948.x. Epub 2009 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare, the number of patients with heartburn and regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole 20 mg or esomeprazole 40 mg.', 'detailedDescription': 'The study is designed to be conducted in a realistic General Practice (GP) setting, enrolling typical Gastro-oesophageal Reflux Disease (GORD) patients that present for treatment, and for whom a Proton Pump Inhibitor (PPI) would normally be prescribed. The study will be conducted over a 4-week period on the basis that current GP standard practice is to treat the GORD patient for a period of 4-weeks prior to reassessment and further follow-up if required. This study is conducted in patients with GORD - associated heartburn (with or without regurgitation) at multiple GP centers, treatment is assigned based on chance (randomized), similar to the toss of a coin and neither doctor or patient knows which treatment they will receive (double-blinded). Following screening to determine eligibility, patients will be randomized to receive oral treatment with either, 20 mg rabeprazole, 20 mg esomeprazole or 40 mg esomeprazole once daily for 4 weeks. This 4-week study encompasses 2 protocol-mandated visits (baseline on day 0 and final visit on day 28). It is hypothesized that rabeprazole 20 mg will be no less effective than (non-inferior) esomeprazole 40 mg for the degree of GORD symptom resolution. Patients will take one tablet (rabeprazole 20 mg or placebo) and one capsule (esomeprazole 20 mg, esomeprazole 40 mg or placebo) each day for 28 days. The study medication will be taken once daily in the morning before breakfast, except the first dose, which will be taken during Visit 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Heartburn (defined as a feeling of burning or pain, rising from the epigastrium or lower part of the chest up towards the neck) with or without regurgitation\n* Patients must have had episodes of heartburn with or without regurgitation for 3 months or longer, and for \\>= 3 days in the 7 days prior to randomisation\n* Able to understand and complete questionnaires, able to give written informed consent, and have access to a telephone\n\nExclusion Criteria:\n\n* Patients requiring endoscopy within 4 weeks of randomisation or with gastrointestinal symptoms that, in the opinion of the investigator, require further investigation prior to or coincident with initiation of PPI therapy which would include, but are not limited to, alarm symptoms such as unintentional weight loss, progressive difficulty swallowing (dysphagia), iron deficiency anaemia and epigastric mass\n* Significant gastrointestinal obstruction, major gastric or oesophageal surgery (excluding appendectomy or cholecystectomy), oesophageal stricture or pyloric stenosis, extra-oesophageal manifestations of reflux disease\n* Patients with Barrett's oesophagus (\\>3cm), Zollinger-Ellison Syndrome, scleroderma, malignancy (other than non-melanoma skin cancers) present within the last 5 years, hypersensitivity to rabeprazole or esomeprazole or any PPI, or any other significant condition that, in the opinion of the investigator, could interfere with the patients participation or compliance in the study such as past or current history of alcohol or drug abuse, hepatic, renal, pulmonary, respiratory abnormalities, or who have participated in an investigational drug or investigational device study within 30 days prior to the baseline visit or who are expected to do so during the 4 week study period\n* Female patients who are currently pregnant or breast feeding, or who, in the opinion of the investigator, may become pregnant throughout the study\n* Use of histamine-2 receptor antagonists (H2RAs) within 7 days of randomisation, anticholinergics, cholinergics, spasmolytics, opiates, sucralfate, proton pump inhibitors (PPIs), prokinetics, antibiotics (in relation to H. pylori treatment) or bismuth compounds within 14 days of randomisation"}, 'identificationModule': {'nctId': 'NCT00464308', 'briefTitle': 'A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag Pty Ltd'}, 'officialTitle': 'The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)', 'orgStudyIdInfo': {'id': 'CR006397'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '001', 'description': 'Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap \\& 1 active tab/cap daily', 'interventionNames': ['Drug: Esomeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '002', 'description': 'Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap \\& 1 active tab/cap daily', 'interventionNames': ['Drug: Esomeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '003', 'description': 'Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap \\& 1 active tab/cap daily', 'interventionNames': ['Drug: Rabeprazole']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'description': '20mg once daily for 28days - 1 placebo tab/cap \\& 1 active tab/cap daily', 'armGroupLabels': ['002']}, {'name': 'Rabeprazole', 'type': 'DRUG', 'description': '20mg once daily for 28days - 1 placebo tab/cap \\& 1 active tab/cap daily', 'armGroupLabels': ['003']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'description': '40mg once daily for 28days - 1 placebo tab/cap \\& 1 active tab/cap daily', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belconnen', 'country': 'Australia', 'geoPoint': {'lat': -35.23798, 'lon': 149.06627}}, {'city': 'Bondi Junction', 'country': 'Australia', 'geoPoint': {'lat': -33.89275, 'lon': 151.24723}}, {'city': 'Brookvale', 'country': 'Australia', 'geoPoint': {'lat': -33.76108, 'lon': 151.27446}}, {'city': 'Browns Plains', 'country': 'Australia', 'geoPoint': {'lat': -36.0472, 'lon': 146.63866}}, {'city': 'Campbelltown', 'country': 'Australia', 'geoPoint': {'lat': -34.06667, 'lon': 150.81667}}, {'city': 'Campsie', 'country': 'Australia', 'geoPoint': {'lat': -33.9125, 'lon': 151.10279}}, {'city': 'Caringbah', 'country': 'Australia', 'geoPoint': {'lat': -34.03534, 'lon': 151.12468}}, {'city': 'Castle Hill', 'country': 'Australia', 'geoPoint': {'lat': -33.73333, 'lon': 151.0}}, {'city': 'Charlestown', 'country': 'Australia', 'geoPoint': {'lat': -32.96828, 'lon': 151.69318}}, {'city': 'Dapto', 'country': 'Australia', 'geoPoint': {'lat': -34.50386, 'lon': 150.79416}}, {'city': 'Darlinghurst', 'country': 'Australia', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'city': 'Dubbo', 'country': 'Australia', 'geoPoint': {'lat': -32.24295, 'lon': 148.60484}}, {'city': 'Elizabeth', 'country': 'Australia', 'geoPoint': {'lat': -34.72, 'lon': 138.67}}, {'city': 'Fairfield', 'country': 'Australia', 'geoPoint': {'lat': -33.86667, 'lon': 150.95}}, {'city': 'Hoppers Crossing', 'country': 'Australia', 'geoPoint': {'lat': -37.88264, 'lon': 144.7003}}, {'city': 'Ingleburn', 'country': 'Australia', 'geoPoint': {'lat': -34.0, 'lon': 150.86667}}, {'city': 'Leichhardt', 'country': 'Australia', 'geoPoint': {'lat': -33.88341, 'lon': 151.15625}}, {'city': 'Maroubra', 'country': 'Australia', 'geoPoint': {'lat': -33.95, 'lon': 151.23333}}, {'city': 'Melton', 'country': 'Australia', 'geoPoint': {'lat': -37.68339, 'lon': 144.58543}}, {'city': 'Mount Druitt', 'country': 'Australia', 'geoPoint': {'lat': -33.76667, 'lon': 150.81667}}, {'city': 'Oaklands Park', 'country': 'Australia', 'geoPoint': {'lat': -35.00671, 'lon': 138.54457}}, {'city': 'Royal Park', 'country': 'Australia', 'geoPoint': {'lat': -34.87415, 'lon': 138.51189}}, {'city': 'Sydney', 'country': 'Australia', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Wentworthville', 'country': 'Australia', 'geoPoint': {'lat': -33.80652, 'lon': 150.96785}}, {'city': 'Wyoming', 'country': 'Australia', 'geoPoint': {'lat': -33.40387, 'lon': 151.36254}}], 'overallOfficials': [{'name': 'Janssen-Cilag Pty Ltd Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag Pty Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}