CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 240 enrolled
Drug / intervention
Rabeprazole ER +1 moredrug
Likely dose
Rabeprazole ER 50 mg orally once daily or Ranitidine 150 mg orally twice daily (both for 26 weeks)AI-extracted
Key inclusion· 1
  • ✓Prior completion of Study E3810-G000-301 or -303 with confirmed healed erosive esophagitis (no mucosal breaks/erosions on EGD) and sustained heartburn resolution at Visit 4 or 5
Key exclusion· 5
  • ✕Esophageal motility disorders including achalasia, scleroderma, or esophageal spasm
  • ✕Barrett's esophagus or esophageal stricture
  • ✕Use of prescription or non-prescription PPIs, H2RAs, antacids, sucralfate, misoprostol, prokinetics, or drugs with significant anticholinergic effects during the study
  • ✕Chronic use of NSAIDs, oral steroids ≥20 mg/day prednisone equivalent, or aspirin >325 mg/day

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00838526
NCT00838526Phase 3Completed
CompareCT.gov

Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

Eisai Inc.·interventional·Posted Feb 6, 2009·Updated Apr 25, 2022

In Brief

A Phase 3 clinical trial evaluating Rabeprazole ER and Ranitidine for Gastroesophageal Reflux Disease (GERD). Completed, enrolled 240 participants across 4 sites.

Detailed Summary

The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease (GERD)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2009
Enrollment StartAug 31, 2008
Primary CompletionJul 31, 2009
Study CompletionDec 31, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.4 years ago

Interventions

Rabeprazole ERdrug

50 mg capsule, taken orally, once daily for 26 weeks.

Ranitidinedrug

150 mg capsule, taken orally, twice daily for 26 weeks.