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

Primary Purpose

Dyspepsia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Itopride
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Abdominal Symptom Relief, Fullness, Bloating, Indigestion, Functional dyspepsia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Long-term safety

    Secondary Outcome Measures

    Long-term relief of symptoms

    Full Information

    First Posted
    May 31, 2005
    Last Updated
    February 6, 2017
    Sponsor
    Forest Laboratories
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00112203
    Brief Title
    Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    September 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Forest Laboratories

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyspepsia
    Keywords
    Abdominal Symptom Relief, Fullness, Bloating, Indigestion, Functional dyspepsia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    466 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Itopride
    Primary Outcome Measure Information:
    Title
    Long-term safety
    Time Frame
    every 2 months
    Secondary Outcome Measure Information:
    Title
    Long-term relief of symptoms
    Time Frame
    every 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan Tack, MD
    Organizational Affiliation
    Universitaire Ziekenhuizen KU Leuven
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jan Tack, MD
    Organizational Affiliation
    University of Leuven
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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