NCT00382577CompletedPhase 3
A Randomized, Double-blind, Two Period, Crossover Study to Evaluate the Effects of a Single Dose of Itopride 200 mg on Esophageal and Gastric pH and Reflux in Patients With Heartburn
Forest Laboratories2 sites in 1 country48 target enrollmentStarted: October 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- 24-hour pH Monitoring
Study Overview
Brief Summary
The purpose of this study is to evaluate the effects of itopride in patients with heartburn.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Otherwise healthy males and females aged 18-70, with at least 3 episodes of heartburn or acid regurgitation per week.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
24-hour pH Monitoring
Time Frame: after 5 days of treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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