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Itopride in Functional Dyspepsia:a Dose Finding Study

2014-08-27 03:46:56 | BioPortfolio

Summary

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.

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Functional Dyspepsia

Intervention

Itopride (drug)

Location

University Hospital Essen
Essen
Germany
45122

Status

Completed

Source

Royal Adelaide Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:46:56-0400

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PubMed Articles [13470 Associated PubMed Articles listed on BioPortfolio]

New Approaches to Diagnosis and Treatment of Functional Dyspepsia.

The purpose of this article is to review the recent literature and discuss the new approaches to the diagnosis and treatment of functional dyspepsia (FD).

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Time trends in dyspepsia and association with H. pylori and work-related stress-An observational study in white collar employees in 1996 and 2015.

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Medical and Biotech [MESH] Definitions

A substituted benzamide used for its prokinetic properties. It is used in the management of gastroesophageal reflux disease, functional dyspepsia, and other disorders associated with impaired gastrointestinal motility. (Martindale The Extra Pharmacopoeia, 31st ed)

The molecular designing of drugs for specific purposes (such as DNA-binding, enzyme inhibition, anti-cancer efficacy, etc.) based on knowledge of molecular properties such as activity of functional groups, molecular geometry, and electronic structure, and also on information cataloged on analogous molecules. Drug design is generally computer-assisted molecular modeling and does not include pharmacokinetics, dosage analysis, or drug administration analysis.

Impaired digestion, especially after eating.

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Infection of humans or animals with hookworms of the genus ANCYLOSTOMA. Characteristics include anemia, dyspepsia, eosinophilia, and abdominal swelling.

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