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Efficacy and Safety of Itopride vs Placebo in Heartburn

This study has been completed.
Information provided by (Responsible Party):
Forest Laboratories Identifier:
First received: September 27, 2006
Last updated: February 7, 2017
Last verified: February 2017
The purpose of this study is to evaluate the effects of itopride in patients with heartburn.

Condition Intervention Phase
Heartburn Drug: Itopride Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (masked roles unspecified)
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 Forest Laboratories:

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)
Sexes Eligible for Study:   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.
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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
Forest Laboratories
Principal Investigator: Philip, Jr. B. Miner, M.D. The Oklahoma Foundation for Digestive Research
  More Information

Responsible Party: Forest Laboratories Identifier: NCT00382577     History of Changes
Other Study ID Numbers: ITOLES06-01
Study First Received: September 27, 2006
Last Updated: February 7, 2017

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on August 16, 2017