Indigestion |
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Clinical Trial: Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
This study is currently recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Dyspepsia | Drug: Itopride Hydrochloride | Phase III |
MedlinePlus related topics: Digestive Diseases; Stomach Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering from Functional Dyspepsia
Secondary Outcomes: Impact of symptom relief on quality of life; Safety
Expected Total Enrollment: 500
Study start: July 2004; Expected completion: January 2006
Last follow-up: November 2005; Data entry closure: January 2006
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.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
Danielle De Montigny 800-565-3255 Ext. 2198 ddemontigny@axcan.com
Canada, Quebec
Monique Giguère, Ph.D. - Programs Director, Mont-Saint-Hilaire, Quebec, J3H 6C4, Canada; Recruiting
Jan Tack, Professor, Principal Investigator, University Hospital Leuven
More Information
Record last reviewed: May 2005
Last Updated: May 31, 2005
Record first received: May 31, 2005
ClinicalTrials.gov Identifier: NCT00112177
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-06-07

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