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Efficacy and Safety of Itopride vs Placebo in Heartburn

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00382577
First received: September 27, 2006
Last updated: February 7, 2017
Last verified: February 2017
  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 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
  Eligibility

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
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
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
Study First Received: September 27, 2006
Last Updated: February 7, 2017

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

ClinicalTrials.gov processed this record on April 25, 2017