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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axcan Pharma; Forest Laboratories

Criteria

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 Criteria:

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