Itopride in Functional Dyspepsia:a Dose Finding Study

This study has been completed.
Sponsor:
Collaborators:
Knoll Pharmaceuticals, Germany (now Abbott)
University Hospital, Essen
Information provided by:
Royal Adelaide Hospital
ClinicalTrials.gov Identifier:
NCT00272103
First received: January 3, 2006
Last updated: May 3, 2006
Last verified: November 2005

January 3, 2006
May 3, 2006
December 2000
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00272103 on ClinicalTrials.gov Archive Site
Safety parameters
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Functional Dyspepsia
Drug: Itopride (drug)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
January 2002
Not Provided

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

-

Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00272103
KD20003
Not Provided
Not Provided
Royal Adelaide Hospital
  • Knoll Pharmaceuticals, Germany (now Abbott)
  • University Hospital, Essen
Principal Investigator: Gerald J Holtmann, MD Royal Adelaide Hospital, University of Adelaide
Royal Adelaide Hospital
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP