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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Axcan Pharma.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00112177
First received: May 31, 2005
Last updated: January 25, 2007
Last verified: August 2006
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:


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

Estimated Enrollment: 500
Study Start Date: July 2004
Estimated Study Completion Date: December 2005
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: NCT00112177

Locations
Canada, Quebec
Monique Giguère, Ph.D. - Programs Director
Mont-Saint-Hilaire, Quebec, Canada, J3H 6C4
Sponsors and Collaborators
Axcan Pharma
Investigators
Principal Investigator: Jan Tack, Professor Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00112177     History of Changes
Other Study ID Numbers: ITOFD04-03
Study First Received: May 31, 2005
Last Updated: January 25, 2007
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 April 22, 2014