Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia

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

Phase

3

Condition

Stomach Discomfort

Heartburn

Colic

Treatment

N/A

Clinical Study ID

NCT00110968
ITOFD04-02
  • Ages 18-65
  • All Genders

Study Summary

Itopride is a compound 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. Patients feel full after eating, they have bloating and have stomach pain. The goal of this study is to see if Itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have completed the 8 week double-blind study ITOFD04-01

  • Female patients must not be pregnant (must have a negative serum pregnancy test)

Exclusion

Exclusion Criteria:

  • Patients with any newly occurring medical condition which was an exclusion criterionat ITOFD04-01 study entry

Study Design

Total Participants: 300
Study Start date:
September 01, 2004
Estimated Completion Date:
September 30, 2006

Study Description

All patients having completed study ITOFD04-01 will be offered to continue to be treated with itopride for a period of up to one year in duration. A target of 300 patients will be followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an additional 6 months.

Patients will need to come to the clinic for evaluations every 8 weeks during the trial. Evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.