COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT00112177
Recruitment Status : Completed
First Posted : June 1, 2005
Last Update Posted : February 8, 2017
Information provided by:
Forest Laboratories

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Primary Outcome Measures :
  1. Symptom relief

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

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00112177

Layout table for location information
Canada, Quebec
Monique Giguère, Ph.D. - Programs Director
Mont-Saint-Hilaire, Quebec, Canada, J3H 6C4
Sponsors and Collaborators
Forest Laboratories
Layout table for investigator information
Principal Investigator: Jan Tack, Professor Universitaire Ziekenhuizen Leuven
Layout table for additonal information
Responsible Party: Monique Giguère, Axcan Pharma inc. Identifier: NCT00112177    
Other Study ID Numbers: ITOFD04-03
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive