NCT00911534CompletedPhase 3
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 305
- Primary Endpoint
- Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Experimental
Intervention: rabeprazole sodium (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
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.
Secondary Outcomes
- Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4(Baseline and Week 4)
Investigators
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