Efficacy and Safety of Itopride vs Placebo in Heartburn

This study has been completed.

First Received: September 27, 2006 Last Updated: May 2, 2007 History of Changes

Sponsored by:	Axcan Pharma
Information provided by:	Axcan Pharma
ClinicalTrials.gov Identifier:	NCT00382577

Purpose

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

Condition	Intervention	Phase
Heartburn	Drug: Itopride	Phase III

MedlinePlus related topics: Heartburn

Drug Information available for: Itopride

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:

Eligibility

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

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

Study ID Numbers:	ITOLES06-01
Study First Received:	September 27, 2006
Last Updated:	May 2, 2007
ClinicalTrials.gov Identifier:	NCT00382577 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Pyrosis
Signs and Symptoms, Digestive

Esophageal Disorder
Heartburn
Esophageal Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Heartburn

ClinicalTrials.gov processed this record on May 07, 2009