Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia

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: NCT00110968
Recruitment Status : Completed
First Posted : May 17, 2005
Last Update Posted : February 8, 2017
Information provided by:
Forest Laboratories

Brief Summary:
Itopride is a compound 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. Patients feel full after eating, they have bloating and have stomach pain. The goal of this study is to see if Itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: Itopride hydrochloride Phase 3

Detailed Description:

All patients having completed study ITOFD04-01 will be offered to continue to be treated with itopride for a period of up to one year in duration. A target of 300 patients will be followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an additional 6 months.

Patients will need to come to the clinic for evaluations every 8 weeks during the trial. Evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open-label Extension Phase to Study the Long-term Safety and Efficacy of Itopride HCl in Patients Suffering From Functional Dyspepsia
Study Start Date : September 2004
Primary Completion Date : July 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Primary Outcome Measures :
  1. Long-term safety

Secondary Outcome Measures :
  1. Long-term relief of symptoms

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

Inclusion Criteria:

  • Patients must have completed the 8 week double-blind study ITOFD04-01
  • Female patients must not be pregnant (must have a negative serum pregnancy test)

Exclusion Criteria:

  • Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-01 study entry

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): NCT00110968

Sponsors and Collaborators
Forest Laboratories
Principal Investigator: Nicholas Talley, MD, PhD Mayo Clinic, Rochester, Minn

Responsible Party: Monique Giguère, Axcan Pharma inc. Identifier: NCT00110968     History of Changes
Other Study ID Numbers: ITOFD04-02
First Posted: May 17, 2005    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by Forest Laboratories:
Abdominal Symptom relief
Functional dyspepsia

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