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Completed

NCT Number: NCT00272103

Itopride in Functional Dyspepsia:a Dose Finding Study

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.

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Key information

Conditions

Functional Dyspepsia

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital Essen

Essen, Hesse, 45122, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Itopride (drug)

Drug

Primary outcomes

  1. After 8 weeks of treatment:

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

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

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

Secondary outcomes

  1. Safety parameters

Sponsors and collaborators

Lead sponsor

Royal Adelaide Hospital

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2000
Study completion
2002
First posted
Jan 4, 2006
Registry last updated
May 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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