NCT00658528

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

A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,061 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive GERD.

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

Type	Name	Description
DRUG	Rabeprazole sodium	Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.
DRUG	Esomeprazole	Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-09-01
• Completion: 2010-01-01
• First posted: 2008-04-15
• Last updated: 2015-12-21
• Results posted: 2015-06-23

Locations

88 sites across 13 countries: United States, Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Estonia, France, Germany, Hungary, India, Latvia