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
  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 2
Phase 3

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

Resource links provided by NLM:


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

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Royal Adelaide Hospital:
functional dyspepsia
non ulcer dyspepsia
drug treatment

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Stomach Diseases

ClinicalTrials.gov processed this record on October 22, 2014