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NCT00658528 · ClinicalTrials.gov registry record · Phase 3
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,061
- Enrollment target
NCT00658528: Completed Phase 3 study, sponsored by Eisai.
NCT00658528 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 1,061 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00658528, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,061 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).
Primary Outcome
Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosa
Interventions
- DRUG Esomeprazole
- DRUG Rabeprazole sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,061 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00658528 record still lists
NCT00658528 is an interventional study that assigns participants to a tested intervention. Its 1,061 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which Esomeprazole is the first listed.
NCT00658528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00658528 about?
NCT00658528 is a clinical study titled "Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)". The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).
What is the current status of trial NCT00658528?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,061 participants. The study started on 2008-02. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00658528?
The interventions under investigation include: Esomeprazole (DRUG), Rabeprazole sodium (DRUG).
Who is sponsoring clinical trial NCT00658528?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00658528's enrollment target sits among peer trials
1,061 275th of 2000 higher than 1,726 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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