NCT00658775

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: 1,069 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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 Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

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

83 sites across 14 countries: United States, Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Estonia, France, Germany, Hungary, India, Latvia, Lithuania