Itopride in Functional Dyspepsia:a Dose Finding Study - Full Text View

Sponsors and Collaborators:	Royal Adelaide Hospital Knoll Pharmaceuticals, Germany (now Abbott) University Hospital, Essen
Information provided by:	Royal Adelaide Hospital
ClinicalTrials.gov Identifier:	NCT00272103

Purpose

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.

Condition	Intervention	Phase
Functional Dyspepsia	Drug: Itopride (drug)	Phase II Phase III

MedlinePlus related topics: Indigestion

Drug Information available for: Itopride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Royal Adelaide Hospital:

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

Estimated Enrollment:	500
Study Start Date:	December 2000
Estimated Study Completion Date:	January 2002

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.

Eligibility

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272103

Locations

Germany
University Hospital Essen
Essen, Germany, 45122

Sponsors and Collaborators

Royal Adelaide Hospital

Knoll Pharmaceuticals, Germany (now Abbott)

University Hospital, Essen

Investigators

Principal Investigator:

Gerald J Holtmann, MD

Royal Adelaide Hospital, University of Adelaide

More Information

Publications of Results:

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.

Study ID Numbers:	KD20003
Study First Received:	January 3, 2006
Last Updated:	May 3, 2006
ClinicalTrials.gov Identifier:	NCT00272103
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Royal Adelaide Hospital:

functional dyspepsia
non ulcer dyspepsia
drug treatment

Study placed in the following topic categories:

Signs and Symptoms
Stomach Diseases
Digestive System Diseases
Signs and Symptoms, Digestive

Gastrointestinal Diseases
Gastroenteritis
Dyspepsia
Gastritis

ClinicalTrials.gov processed this record on January 16, 2009