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

This study has been completed.
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00112190
First received: May 31, 2005
Last updated: July 24, 2008
Last verified: July 2008
History of Changes
  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 Intervention Phase
Dyspepsia
 Drug: Itopride Hydrochloride
Drug: itopride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:
  • Symptom relief

Secondary Outcome Measures:
  • Impact of symptom relief on quality of life
  • Safety

Enrollment: 645
Study Start Date: July 2004
Study Completion Date: March 2006
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Itopride Hydrochloride
    100 mg tid
    Drug: itopride
    100 mg three times daily
Detailed Description:

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 to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112190

Locations
Canada, Quebec
AXCAN Pharma Inc.
Mont St-Hilaire, Quebec, Canada, J3H 6C4
Sponsors and Collaborators
Axcan Pharma
Investigators
Principal Investigator: Nicholas Talley, MD Mayo Clinic, Rochester, Minn
  More Information

No publications provided

Responsible Party: Dr. N. Talley, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00112190     History of Changes
Other Study ID Numbers: ITOFD04-01
Study First Received: May 31, 2005
Last Updated: July 24, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Axcan Pharma:
Functional dyspepsia
Abdominal Symptom relief
Fullness
Bloating
Indigestion

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013