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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Axcan Pharma; Forest Laboratories

Criteria

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