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Itopride HCl in Functional Dyspepsia
NCT00112190Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2004
- Primary completion
- Mar 2005
- Countries
- 1
- Sponsor
- Forest Laboratories
- Modality
- Small Molecules
- Drugs
- itopride
- Conditions
- functional dyspepsia (FD)
01
Overview
Phase 3, randomised, double-blind trial in functional dyspepsia (FD) comparing Itopride with Placebo (2 arms). Primary endpoints: Global Patient Assessment of Efficacy at 8 weeks and Leeds Dyspepsia Questionnaire at 8 weeks. Started Jul 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Itopride
Itopride Hydrochloride 100 mg tid
Placebo
Placebo tid
03
Who it enrols
Patients 18-65 years old with functional dyspepsia according to Rome II criteria, H. pylori negative, and normal upper endoscopy.
04
Endpoints
Primary
Global Patient Assessment of Efficacy
Leeds Dyspepsia Questionnaire
Secondary
Quality of Life
Safety and Tolerability
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