CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 619 enrolled
Drug / intervention
rabeprazole sodium +1 moredrug
Likely dose
Rabeprazole 10 mg orally once dailyAI-extracted
Key inclusion· 3
  • Age >18 years
  • History of heartburn at least 2 days per week over the past month
  • Female: not of childbearing potential, or if of childbearing potential, using approved contraception with negative pregnancy test
Key exclusion· 5
  • History of erosive esophagitis verified by endoscopy
  • History of gastroesophageal reflux disease (GERD) diagnosed by a physician
  • History of Barrett's esophagus or esophageal stricture
  • Continuous use of proton pump inhibitors, H2 blockers, or prokinetics (intermittent prior use allowed if discontinued appropriately)

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

Search/NCT00236197
NCT00236197Phase 3Completed

E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Eisai Inc.·interventional·Posted Oct 12, 2005·Updated Nov 11, 2009

In Brief

A Phase 3 clinical trial evaluating rabeprazole sodium and placebo for Heartburn. Completed, enrolled 619 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeartburn
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2005
Enrollment StartOct 1, 2005
Primary CompletionMar 1, 2006
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 20.7 years ago

Interventions

rabeprazole sodiumdrug

Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally,placebo once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.

placebodrug

Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.