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Itopride in Functional Dyspepsia:a Dose Finding Study

Primary Purpose

Functional Dyspepsia

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Itopride (drug)

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring functional dyspepsia, non ulcer dyspepsia, drug treatment

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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 -

Sites / Locations

University Hospital Essen

Outcomes

Primary Outcome Measures

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 Outcome Measures

Safety parameters

Full Information

NCT ID

NCT00272103

First Posted

January 3, 2006

Last Updated

May 3, 2006

Sponsor

Royal Adelaide Hospital

Collaborators

Knoll Pharmaceuticals, Germany (now Abbott), University Hospital, Essen

1. Study Identification

Unique Protocol Identification Number

NCT00272103

Brief Title

Itopride in Functional Dyspepsia:a Dose Finding Study

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2005

Overall Recruitment Status

Completed

Study Start Date

December 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Royal Adelaide Hospital

Collaborators

Knoll Pharmaceuticals, Germany (now Abbott), University Hospital, Essen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Dyspepsia

Keywords

functional dyspepsia, non ulcer dyspepsia, drug treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

500 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Itopride (drug)

Primary Outcome Measure Information:

Title

After 8 weeks of treatment:

Title

Change of the severity of functional dyspepsia symptoms assessed by the Leeds Dyspepsia Questionnaire)

Title

Patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)

Title

Improvement of pain and/or fullness by at least one grade on a 5-grade scale.

Secondary Outcome Measure Information:

Title

Safety parameters

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerald J Holtmann, MD

Organizational Affiliation

Royal Adelaide Hospital, University of Adelaide

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Essen

City

Essen

ZIP/Postal Code

45122

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

16495395

Citation

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. doi: 10.1056/NEJMoa052639. Erratum In: N Engl J Med. 2006 Jul 27;355(4):429.

Results Reference

result

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Itopride in Functional Dyspepsia:a Dose Finding Study

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