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

This study is ongoing, but not recruiting participants.
Information provided by:
Axcan Pharma Identifier:
First received: May 31, 2005
Last updated: January 25, 2007
Last verified: January 2007
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 Intervention Phase
Drug: Itopride Hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:
  • Long-term safety

Secondary Outcome Measures:
  • Long-term relief of symptoms

Estimated Enrollment: 300
Study Start Date: November 2004
Estimated Study Completion Date: August 2006
Detailed Description:

All patients who have completed study ITOFD04-03 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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have completed the 8 week double-blind study ITOFD04-03
  • 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 ITOFD04-03 study entry
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00112203

Sponsors and Collaborators
Axcan Pharma
Principal Investigator: Jan Tack, MD Leuven University
Principal Investigator: Jan Tack, MD University of Leuven
  More Information Identifier: NCT00112203     History of Changes
Other Study ID Numbers: ITOFD04-04 
Study First Received: May 31, 2005
Last Updated: January 25, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Axcan Pharma:
Abdominal Symptom Relief
Functional dyspepsia

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on January 14, 2017