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

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ClinicalTrials.gov Identifier: NCT00112190
Recruitment Status : Completed
First Posted : June 1, 2005
Last Update Posted : February 8, 2017
Sponsor:
Information provided by:
Forest Laboratories

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Dyspepsia Drug: Itopride Hydrochloride Drug: itopride Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Drug: Itopride Hydrochloride
    100 mg tid
    Drug: itopride
    100 mg three times daily

Outcome Measures
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Primary Outcome Measures :
  1. Symptom relief

Secondary Outcome Measures :
  1. Impact of symptom relief on quality of life
  2. Safety

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112190


Locations
Canada, Quebec
AXCAN Pharma Inc.
Mont St-Hilaire, Quebec, Canada, J3H 6C4
Sponsors and Collaborators
Forest Laboratories
Investigators
Principal Investigator: Nicholas Talley, MD Mayo Clinic, Rochester, Minn
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr. N. Talley, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00112190     History of Changes
Other Study ID Numbers: ITOFD04-01
First Posted: June 1, 2005    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by Forest Laboratories:
Functional dyspepsia
Abdominal Symptom relief
Fullness
Bloating
Indigestion

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