Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

645 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-03-31

Brief Summary

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Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. They feel full after eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia.

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Detailed Description

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The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a sugar pill called placebo. They have equal chances of receiving either treatment. After having completed this study, patients may be eligible to continue treatment for a longer period. At that point, all patients receive itopride.

Patients need to come to the clinic for evaluations 4 times during the trial. Various evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the heart condition, and questionnaires need to be completed by the patient to see if the drug helps them in relieving their symptoms.

Conditions

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Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Itopride Hydrochloride

100 mg tid

Intervention Type DRUG

itopride

100 mg three times daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from functional dyspepsia according to Rome II criteria

* 18-65 years old
* Absence of, or infrequent heartburn (one episode per week or less)
* Helicobacter pylori (H. pylori) negative
* Normal upper endoscopy

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No