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Efficacy and Safety of Itopride vs Placebo in Heartburn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00382577
Recruitment Status : Completed
First Posted : September 29, 2006
Last Update Posted : February 9, 2017
Information provided by (Responsible Party):
Forest Laboratories

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

Condition or disease Intervention/treatment Phase
Heartburn Drug: Itopride Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : October 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn

Primary Outcome Measures :
  1. 24-hour pH Monitoring [ Time Frame: after 5 days of treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00382577

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United States, Oklahoma
The Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Forest Laboratories
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Principal Investigator: Philip, Jr. B. Miner, M.D. The Oklahoma Foundation for Digestive Research
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Responsible Party: Forest Laboratories Identifier: NCT00382577    
Other Study ID Numbers: ITOLES06-01
First Posted: September 29, 2006    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive