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NCT00658775 · 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
- 1,069
- Enrollment target
NCT00658775: Completed Phase 3 study, sponsored by Eisai.
NCT00658775 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 1,069 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00658775, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,069 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).
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 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 br
Interventions
- DRUG Esomeprazole
- DRUG Rabeprazole sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,069 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00658775 record still lists
NCT00658775 is an interventional study that assigns participants to a tested intervention. Its 1,069 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 (38% higher).
The record links to 0 conditions, and to 2 interventions - of which Esomeprazole is the first listed.
NCT00658775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00658775 about?
NCT00658775 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 investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).
What is the current status of trial NCT00658775?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,069 participants. The study started on 2008-02. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00658775?
The interventions under investigation include: Esomeprazole (DRUG), Rabeprazole sodium (DRUG).
Who is sponsoring clinical trial NCT00658775?
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 NCT00658775's enrollment target sits among peer trials
1,069 272nd of 2000 higher than 1,729 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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