Status:
COMPLETED
Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
Lead Sponsor:
Forest Laboratories
Conditions:
Dyspepsia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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...
Detailed 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 thi...
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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
645 Patients enrolled
Trial Details
Trial ID
NCT00112190
Start Date
July 1 2004
End Date
March 1 2006
Last Update
February 8 2017
Active Locations (1)
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1
AXCAN Pharma Inc.
Mont St-Hilaire, Quebec, Canada, J3H 6C4