A Randomized Double-Blind Parallel Study of Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Overview
- Phase
- Phase 3
- Intervention
- Rabeprazole ER
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Sponsor
- Eisai Inc.
- Enrollment
- 240
- Locations
- 3
- Primary Endpoint
- Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to compare the efficacy of rabeprazole extended release 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive gastroesophageal reflux disease (eGERD).
Detailed Description
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily). Please note that this study is not a duplicate of E3810-G000-305; this is a separate study being conducted along with -305.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Intervention: Rabeprazole ER
2
Intervention: Ranitidine
Outcomes
Primary Outcomes
Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
Time Frame: Baseline to Week 26
eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal mucosa (however, edema, erythema, or friability may be present). Grade 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. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Grade D: Mucosal breaks involving at least 75% of the esophageal circumference.
Secondary Outcomes
- Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26(Baseline to Week 26)