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Efficacy and Safety of Itopride vs Placebo in Heartburn

This study has been completed.
Information provided by:
Axcan Pharma Identifier:
First received: September 27, 2006
Last updated: May 2, 2007
Last verified: May 2007
The purpose of this study is to evaluate the effects of itopride in patients with heartburn.

Condition Intervention Phase
Drug: Itopride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:
  • 24-hour ph Monitoring [ Time Frame: after 5 days of treatment ]

Enrollment: 48
Study Start Date: October 2006
Study Completion Date: December 2006

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00382577

United States, Oklahoma
The Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Axcan Pharma
Principal Investigator: Philip, Jr. B. Miner, M.D. The Oklahoma Foundation for Digestive Research
  More Information Identifier: NCT00382577     History of Changes
Other Study ID Numbers: ITOLES06-01 
Study First Received: September 27, 2006
Last Updated: May 2, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on December 05, 2016