Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal

Last updated: February 6, 2017
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

3

Condition

Heartburn (Pediatric)

Colic

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT00112177
ITOFD04-03
  • Ages 18-65
  • All Genders

Study Summary

Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. They feel full after eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients suffering from functional dyspepsia according to Rome II criteria

  • 18-65 years old

  • Absence of, or infrequent heartburn (one episode per week or less)

  • Helicobacter pylori (H. pylori) negative

  • Normal upper endoscopy

Study Design

Total Participants: 500
Study Start date:
July 01, 2004
Estimated Completion Date:
August 31, 2006

Study Description

The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a sugar pill called placebo. They have equal chances of receiving either treatment. After having completed this study, patients may be eligible to continue treatment for a longer period. At that point, all patients receive itopride.

Patients need to come to the clinic for evaluations 4 times during the trial. Various evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the heart condition, and questionnaires need to be completed by the patient to see if the drug helps them in relieving their symptoms.

Connect with a study center

  • Monique Giguère, Ph.D. - Programs Director

    Mont-Saint-Hilaire, Quebec J3H 6C4
    Canada

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.