NCT00272103

Itopride in Functional Dyspepsia:a Dose Finding Study

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Dose Finding Study in 4 Parallel Groups to Establish the Efficacy and Safety of an Eight Week Treatment With Itopride Three Times Daily Compared to Placebo in Patients Suffering From Functional Dyspepsia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (planned)
• Sponsor: Royal Adelaide Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the treatment of patients with functional dyspepsia. The study will test in patients with functional dyspepsia the hypothesis that itopride is superior to placebo with regard to the improvement of symptoms.

Detailed description

Treatment of patients with functional dyspepsia remains unsatisfactory. We will assess the efficacy of Itopride, a D2 antagonist with acetylcholinesterase effects in patients with functional dyspepsia. Patients with functional dyspepsia will be randomized to Itopride (50, 100 or 200 mg tid) or placebo. After 8 weeks of treatment, three primary efficacy endpoints will be analyzed: a) change of the severity of functional dyspepsia symptoms (assessed by the Leeds Dyspepsia Questionnaire), b) patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)and c) improvement of pain and/or fullness by at least one grade on a 5-grade scale.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Itopride (drug)

Timeline

• Start date: 2000-12-01
• Completion: 2002-01-01
• First posted: 2006-01-04
• Last updated: 2006-05-04

Locations

1 site across 1 country: Germany