Itopride in Functional Dyspepsia:a Dose Finding Study

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272103
• Other study ID #: KD20003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 3, 2006
• Last updated: May 3, 2006
• Start date: December 2000
• Est. completion date: January 2002

Study information

• Verified date: November 2005
• Source: Royal Adelaide Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• Itopride (drug)

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen

Sponsors (3)

Lead Sponsor	Collaborator
Royal Adelaide Hospital	Knoll Pharmaceuticals, Germany (now Abbott), University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C. A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med. 2006 Feb 23;354(8):832-40. Erratum in: N Engl J Med. 2006 Jul 27;355(4):429. — View Citation

Outcome

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