Efficacy and Safety of Itopride vs Placebo in Heartburn

This study has been completed.
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00382577
First received: September 27, 2006
Last updated: May 2, 2007
Last verified: May 2007
  Purpose

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


Condition Intervention Phase
Heartburn
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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382577

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

No publications provided

ClinicalTrials.gov 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:
Heartburn
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 20, 2014