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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

May 16, 2005
July 24, 2008
September 2004
July 2006   (final data collection date for primary outcome measure)
Long-term safety
Same as current
Complete list of historical versions of study NCT00110968 on ClinicalTrials.gov Archive Site
Long-term relief of symptoms
Same as current
Not Provided
Not Provided
 
Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
A Multicentre, Open-Label Extension Phase to Study the Long-Term Safety and Efficacy of Itopride HCl in Patients Suffering From Functional Dyspepsia

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.

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.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dyspepsia
Drug: Itopride hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
September 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00110968
ITOFD04-02
Not Provided
Monique Giguère, Axcan Pharma inc.
Axcan Pharma
Not Provided
Principal Investigator: Nicholas Talley, MD, PhD Mayo Clinic, Rochester, Minn
Axcan Pharma
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP