Status:
COMPLETED
Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
Lead Sponsor:
Forest Laboratories
Conditions:
Dyspepsia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 c...
Detailed Description
All patients who have completed study ITOFD04-03 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 ...
Eligibility Criteria
Inclusion
- Patients must have completed the 8 week double-blind study ITOFD04-03
- Female patients must not be pregnant (must have a negative serum pregnancy test)
Exclusion
- Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-03 study entry
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT00112203
Start Date
November 1 2004
End Date
September 1 2006
Last Update
February 8 2017
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