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Efficacy and Safety of Itopride vs Placebo in Heartburn

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00382577
First Posted: September 29, 2006
Last Update Posted: February 9, 2017
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.
Information provided by (Responsible Party):
Forest Laboratories
  Purpose
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
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
  Eligibility

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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00382577     History of Changes
Other Study ID Numbers: ITOLES06-01
First Submitted: September 27, 2006
First Posted: September 29, 2006
Last Update Posted: February 9, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms