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NCT00839306 · ClinicalTrials.gov registry record · Phase 3
Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
A Phase 3 study of Gastroesophageal Reflux Disease (GERD), sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 4
- Study locations
NCT00839306: Completed Phase 3 study of Gastroesophageal Reflux Disease (GERD), sponsored by Eisai.
NCT00839306 is a Phase 3 study of Gastroesophageal Reflux Disease (GERD) that has completed, run by Eisai. The registered enrollment target is 240 participants, below the 2,485-participant average among 5 other Gastroesophageal Reflux Disease (GERD) trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00839306, a Phase 3 study of Gastroesophageal Reflux Disease (GERD), has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 4
- Study locations
Study 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).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Rabeprazole ER
- DRUG Ranitidine
Study Locations (4)
Illinois
- Associates, Ltd. - Moline
- Midwest Clinical - Moline
- Research - Moline
- - Moline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2008-08 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00839306 record still lists
NCT00839306 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 2,485-participant average among 5 other Gastroesophageal Reflux Disease (GERD) trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Gastroesophageal Reflux Disease (GERD) appearing as the primary indexed condition, and to 2 interventions - of which Rabeprazole ER is the first listed.
NCT00839306 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT00839306 about?
NCT00839306 is a clinical study titled "Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)". 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).
What is the current status of trial NCT00839306?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2008-08. Estimated completion is 2010-01.
What conditions does trial NCT00839306 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux Disease (GERD).
What interventions are being tested in trial NCT00839306?
The interventions under investigation include: Rabeprazole ER (DRUG), Ranitidine (DRUG).
Who is sponsoring clinical trial NCT00839306?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00839306 being conducted?
This trial has 4 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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