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

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

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
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
Actual Primary Completion Date : July 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Long-term safety

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00110968


Sponsors and Collaborators
Forest Laboratories
Investigators
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Principal Investigator: Nicholas Talley, MD, PhD Mayo Clinic, Rochester, Minn
More Information
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Responsible Party: Monique Giguère, Axcan Pharma inc.
ClinicalTrials.gov Identifier: NCT00110968    
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
Fullness
Bloating
Indigestion
Functional dyspepsia
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive