NCT00839306

Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily). Please note that this study is not a duplicate of E3810-G000-305; this is a separate study being conducted along with -305.

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

Type	Name	Description
DRUG	Rabeprazole ER	50 mg capsule, taken orally, once daily for 26 weeks.
DRUG	Ranitidine	150 mg capsule, taken orally, twice daily for 26 weeks.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-08-01
• Completion: 2010-01-01
• First posted: 2009-02-09
• Last updated: 2016-02-08
• Results posted: 2015-11-16

Locations

4 sites across 1 country: United States