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Completed

NCT Number: NCT00112190

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

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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Key information

Conditions

Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AXCAN Pharma Inc.

Mont St-Hilaire, Quebec, J3H 6C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Itopride Hydrochloride

Drug

100 mg tid

Itopride

Drug

100 mg three times daily

Primary outcomes

  1. Symptom relief

Secondary outcomes

  1. Impact of symptom relief on quality of life

  2. Safety

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Jun 1, 2005
Registry last updated
Feb 8, 2017

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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