Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-02-19 @ 11:43 AM
Study NCT ID:
NCT00658632
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2008-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064750', 'term': 'Rabeprazole'}, {'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'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'}, {'id': 'D009853', 'term': 'Omeprazole'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '888-422-4743', 'title': 'Eisai Medical Services', 'organization': 'Eisai Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For each participant, from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug or up to resolution of adverse event or up to approximately 10 weeks.', 'description': 'Data are presented as number of participants with treatment emergent adverse events. The analysis was performed using the Safety Analysis Set (SAS), defined as all subjects who received at least 1 dose of study drug and had a postbaseline safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'ESO 40 mg', 'description': 'ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.', 'otherNumAtRisk': 676, 'otherNumAffected': 0, 'seriousNumAtRisk': 676, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'RAB ER 50 mg', 'description': 'RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.', 'otherNumAtRisk': 685, 'otherNumAffected': 0, 'seriousNumAtRisk': 685, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Neuroendocrine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Rectosigmoid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 685, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ESO 40 mg', 'description': 'ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.'}, {'id': 'OG001', 'title': 'RAB ER 50 mg', 'description': 'RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '41.9', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000'}, {'value': '47.1', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ESO 40 mg', 'description': 'ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.'}, {'id': 'OG001', 'title': 'RAB ER 50 mg', 'description': 'RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include:\n\nNot Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).\n\nGrade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.\n\nGrade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.\n\nGread D: Mucosal breaks involving at least 75% of the esophageal circumference.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using the Intent-to-Treat (ITT) population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ESO 40 mg', 'description': 'ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.'}, {'id': 'OG001', 'title': 'RAB ER 50 mg', 'description': 'RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000'}, {'value': '75.9', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 4', 'description': 'Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include:\n\nNot Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).\n\nGrade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.\n\nGrade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.\n\nGread D: Mucosal breaks involving at least 75% of the esophageal circumference.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esomeprazole (ESO) 40 mg', 'description': 'ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.'}, {'id': 'FG001', 'title': 'Rabeprazole (RAB) Extended Release (ER) 50 mg', 'description': 'RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Treated', 'groupId': 'FG000', 'numSubjects': '682'}, {'comment': 'Treated', 'groupId': 'FG001', 'numSubjects': '698'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '618'}, {'groupId': 'FG001', 'numSubjects': '633'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': 'Out of 1397 participants who were randomized, 1380 participants received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'BG000'}, {'value': '697', 'groupId': 'BG001'}, {'value': '1378', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ESO 40 mg', 'description': 'ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.'}, {'id': 'BG001', 'title': 'RAB ER 50 mg', 'description': 'RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '13.16', 'groupId': 'BG000'}, {'value': '47', 'spread': '13.02', 'groupId': 'BG001'}, {'value': '46.8', 'spread': '13.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '379', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '330', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '648', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis was performed using the Intent-to-Treat (ITT) population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1397}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2008-04-09', 'resultsFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2008-04-14', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-08', 'studyFirstPostDateStruct': {'date': '2008-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks', 'timeFrame': 'Baseline and Week 8', 'description': 'Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include:\n\nNot Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).\n\nGrade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.\n\nGrade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.\n\nGread D: Mucosal breaks involving at least 75% of the esophageal circumference.'}, {'measure': 'Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks', 'timeFrame': 'Baseline and Week 4', 'description': 'Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include:\n\nNot Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).\n\nGrade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.\n\nGrade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.\n\nGread D: Mucosal breaks involving at least 75% of the esophageal circumference.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4', 'timeFrame': 'Week 4', 'description': 'During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.'}]}, 'conditionsModule': {'keywords': ['GERD', 'erosive GERD', 'erosive esophagitis'], 'conditions': ['Gastroesophageal Reflux Disease (GERD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).', 'detailedDescription': 'This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of mild to moderate erosive Gastroesophageal Reflux Disease (GERD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "KEY INCLUSION CRITERIA:\n\n1. Male or female, ages 18 to 75 years.\n2. History of gastroesophageal reflux disease (GERD) symptoms for at least 3 months immediately before screening.\n3. Heartburn for at least 2 days a week for at least 1 month before screening.\n4. Esophageal erosions of Los Angeles (LA) Grades A or B based on EGD taken within 14 days prior to enrollment.\n5. Subjects who are H. pylori negative based on a screening test.\n6. Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception.\n7. Subjects must be able to read, write, and understand the language of the symptom diary.\n\nKEY EXCLUSION CRITERIA:\n\n1. Current or a history of esophageal motility disorders.\n2. Current or a history of Barrett's esophagus. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).\n3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.\n4. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.\n5. Inflammatory bowel disease.\n6. Unstable diabetes mellitus.\n7. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.\n8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\\>=20 mg/day prednisone or equivalent), or aspirin (\\> 325 mg/day)."}, 'identificationModule': {'nctId': 'NCT00658632', 'briefTitle': 'Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)', 'orgStudyIdInfo': {'id': 'E3810-G000-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Rabeprazole sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Esomeprazole']}], 'interventions': [{'name': 'Rabeprazole sodium', 'type': 'DRUG', 'otherNames': ['Aciphex'], 'description': 'Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.', 'armGroupLabels': ['1']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'description': 'Esomeprazole 40 mg capsule, once daily for 4-8 weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72120', 'city': 'Sherwood', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.81509, 'lon': 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