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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00272103

Enrollment

500

Registered

2006-01-04

Start date

2000-12-31

Completion date

2002-01-31

Last updated

2006-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

Keywords

functional dyspepsia, non ulcer dyspepsia, drug treatment

Brief 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.

Interventions

DRUGItopride (drug)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

Inclusion criteria

Diagnosis of functional dyspepsia (Rome criteria) -

Exclusion criteria

structural or biochemical abnormalities explaining the symptoms, concomitant symptoms of gastroesophageal reflux disease or irritable bowel syndrome dominating the clinical picture \-

Design outcomes

Primary

Measure	Time frame
After 8 weeks of treatment:	—
Change of the severity of functional dyspepsia symptoms assessed by the Leeds Dyspepsia Questionnaire)	—
Patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)	—
Improvement of pain and/or fullness by at least one grade on a 5-grade scale.	—

Secondary

Measure	Time frame
Safety parameters	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026