NCT00236197

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 619 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.

Conditions

• Heartburn

Interventions

Type	Name	Description
DRUG	rabeprazole sodium	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.
DRUG	placebo	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.

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-03-01
• Completion: 2008-06-01
• First posted: 2005-10-12
• Last updated: 2009-11-11
• Results posted: 2009-11-05

Locations

1 site across 1 country: United States