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Sponsors and Collaborators: |
Royal Adelaide Hospital Knoll Pharmaceuticals, Germany (now Abbott) University Hospital, Essen |
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Information provided by: | Royal Adelaide Hospital |
ClinicalTrials.gov Identifier: | NCT00272103 |
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 |
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Functional Dyspepsia |
Drug: Itopride (drug) |
Phase II Phase III |
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 |
Estimated Enrollment: | 500 |
Study Start Date: | December 2000 |
Estimated Study Completion Date: | January 2002 |
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.
Ages Eligible for Study: | 18 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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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Germany | |
University Hospital Essen | |
Essen, Germany, 45122 |
Principal Investigator: | Gerald J Holtmann, MD | Royal Adelaide Hospital, University of Adelaide |
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 |
functional dyspepsia non ulcer dyspepsia drug treatment |
Signs and Symptoms Stomach Diseases Digestive System Diseases Signs and Symptoms, Digestive |
Gastrointestinal Diseases Gastroenteritis Dyspepsia Gastritis |