Back to resultsEfficacy and Safety of Itopride vs Placebo in Heartburn
Primary Purpose
Heartburn
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Itopride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heartburn
Eligibility Criteria
Inclusion Criteria:
- Otherwise healthy males and females aged 18-70, with at least 3 episodes of heartburn or acid regurgitation per week.
Sites / Locations
- The Oklahoma Foundation for Digestive Research
Outcomes
Primary Outcome Measures
24-hour pH Monitoring
Secondary Outcome Measures
Full Information
NCT ID
NCT00382577
First Posted
September 27, 2006
Last Updated
February 7, 2017
Sponsor
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00382577
Brief Title
Efficacy and Safety of Itopride vs Placebo in Heartburn
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of itopride in patients with heartburn.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Itopride
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
24-hour pH Monitoring
Time Frame
after 5 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Otherwise healthy males and females aged 18-70, with at least 3 episodes of heartburn or acid regurgitation per week.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip, Jr. B. Miner, M.D.
Organizational Affiliation
The Oklahoma Foundation for Digestive Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
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Efficacy and Safety of Itopride vs Placebo in Heartburn
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