- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00112203
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
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Long-term safety
Time Frame: every 2 months
|
every 2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Long-term relief of symptoms
Time Frame: every 2 months
|
every 2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan Tack, MD, University of Leuven
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITOFD04-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Forest LaboratoriesCompleted
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