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

This study has been completed.
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00110968
First received: May 16, 2005
Last updated: July 24, 2008
Last verified: July 2008
History of Changes
  Purpose

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
Dyspepsia
 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:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

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: September 2004
Study Completion Date: September 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110968

Sponsors and Collaborators
Axcan Pharma
Investigators
Principal Investigator: Nicholas Talley, MD, PhD Mayo Clinic, Rochester, Minn
  More Information

No publications provided

Responsible Party: Monique Giguère, Axcan Pharma inc.
ClinicalTrials.gov Identifier: NCT00110968     History of Changes
Other Study ID Numbers: ITOFD04-02
Study First Received: May 16, 2005
Last Updated: July 24, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Axcan Pharma:
Abdominal Symptom relief
Fullness
Bloating
Indigestion
Functional dyspepsia

Additional relevant MeSH terms:
Dyspepsia
Stress, Psychological
Signs and Symptoms, Digestive
Signs and Symptoms
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013