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Long-term Safety and Efficacy of Itopride HCl in Functional Dyspepsia
NCT00110968Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2004
- Primary completion
- Jul 2006
- Sponsor
- Forest Laboratories
- Modality
- Small Molecules
- Drugs
- itopride
- Conditions
- functional dyspepsia (FD)
01
Overview
Phase 3, open-label, single-arm trial of itopride in functional dyspepsia (FD), sponsored by Forest Laboratories. Primary endpoint: Long-term safety. Started Sep 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Extension Arm
All patients receive Itopride hydrochloride
03
Who it enrols
Patients must have completed the 8 week double-blind study ITOFD04-01. Female patients must not be pregnant.
04
Endpoints
Primary
Long-term safety
Secondary
Long-term relief of symptoms
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