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Efficacy and Safety of Itopride vs Placebo in Heartburn

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ClinicalTrials.gov Identifier: NCT00382577
Recruitment Status : Completed
First Posted : September 29, 2006
Last Update Posted : February 9, 2017
Sponsor:
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

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

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00382577


Locations
United States, Oklahoma
The Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Forest Laboratories
Investigators
Principal Investigator: Philip, Jr. B. Miner, M.D. The Oklahoma Foundation for Digestive Research

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00382577     History of Changes
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:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms