A Multicenter Randomized Double-Blind Study to Compare the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)

Eisai Inc.0 sites305 target enrollmentJanuary 2009

ConditionsSymptomatic Gastroesophageal Reflux Disease (sGERD)

Interventionsrabeprazole sodium Placebo

Drugsrabeprazole sodium Placebo

Overview

Phase: Phase 3
Intervention: rabeprazole sodium
Conditions: Symptomatic Gastroesophageal Reflux Disease (sGERD)
Sponsor: Eisai Inc.
Enrollment: 305
Primary Endpoint: Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD).

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

October 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

Intervention: rabeprazole sodium

2

Intervention: Placebo

Outcomes

Primary Outcomes

Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4

Time Frame: Week 4

Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.