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NCT00382577 Clinical Trial

Efficacy and Safety of Itopride vs Placebo in Heartburn

Heartburn Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00382577
Other study ID # ITOLES06-01
Secondary ID
Status Completed
Phase Phase 3
First received September 27, 2006
Last updated February 7, 2017
Start date October 2006
Est. completion date December 2006

Study information
Verified date February 2017
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of itopride in patients with heartburn.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Otherwise healthy males and females aged 18-70, with at least 3 episodes of heartburn or acid regurgitation per week.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Itopride

• Placebo

Locations
Country Name City State
United States The Oklahoma Foundation for Digestive Research Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 24-hour pH Monitoring after 5 days of treatment
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