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


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Naftifine Hydrochloride Topical

Naftin


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.

Sponsored by: Axcan Pharma
Information provided by: Axcan Pharma

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

Further Study Details: 
Primary Outcomes: Symptom relief
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

Please refer to this study by ClinicalTrials.gov identifier  NCT00112190

Monique Giguere, PhD      800-565-3255  Ext. 2078    mgiguere@axcan.com
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

Study chairs or principal investigators

Nicholas Talley, MD,  Principal Investigator,  Mayo Clinic, Rochester, Minn   

More Information

Study ID Numbers:  ITOFD04-01
Record last reviewed:  May 2005
Last Updated:  May 31, 2005
Record first received:  May 31, 2005
ClinicalTrials.gov Identifier:  NCT00112190
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-06-07


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October 16, 2008



Page Updated: June 1, 2005
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