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NCT00658632 · ClinicalTrials.gov registry record · Phase 3

Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)

A Phase 3 study, sponsored by Eisai.

Completed
Registry status
Phase 3
Development phase
1,397
Enrollment target

NCT00658632: Completed Phase 3 study, sponsored by Eisai.

NCT00658632 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 1,397 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00658632, a Phase 3 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 3
Development phase
1,397 participants
Enrollment target

Study Summary

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).

Primary Outcome

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: 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

Interventions

  • DRUG Esomeprazole
  • DRUG Rabeprazole sodium

Trial Details

FieldValue
Enrollment Target 1,397 participants
Start Date 2008-02
Est. Completion 2009-09
Phase Phase 3
Eisai

287 total trials

What the finished NCT00658632 record still lists

NCT00658632 is an interventional study that assigns participants to a tested intervention. Its 1,397 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 (81% higher).

The record links to 0 conditions, and to 2 interventions - of which Esomeprazole is the first listed.

NCT00658632 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00658632 about?

NCT00658632 is a clinical study titled "Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)". 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).

What is the current status of trial NCT00658632?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,397 participants. The study started on 2008-02. Estimated completion is 2009-09.

What interventions are being tested in trial NCT00658632?

The interventions under investigation include: Esomeprazole (DRUG), Rabeprazole sodium (DRUG).

Who is sponsoring clinical trial NCT00658632?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00658632's enrollment target sits among peer trials

1,397 175th of 2000 higher than 1,825 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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Source: ClinicalTrials.gov NCT00658632, the US trial registry maintained by the National Library of Medicine. NCT00658632 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.