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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:
ClinicalTrials.gov Identifier:
NCT00112190
First Posted: June 1, 2005
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Forest Laboratories
  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
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

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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

Responsible Party: Dr. N. Talley, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00112190     History of Changes
Other Study ID Numbers: ITOFD04-01
First Submitted: May 31, 2005
First Posted: June 1, 2005
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