NCT00658632

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,397 (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 and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with 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 mild to moderate erosive Gastroesophageal Reflux Disease (GERD).

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: 2009-04-01
• Completion: 2009-09-01
• First posted: 2008-04-15
• Last updated: 2016-05-04
• Results posted: 2015-06-23

Locations

85 sites across 1 country: United States