- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00112190
Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a sugar pill called placebo. They have equal chances of receiving either treatment. After having completed this study, patients may be eligible to continue treatment for a longer period. At that point, all patients receive itopride.
Patients need to come to the clinic for evaluations 4 times during the trial. Various evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the heart condition, and questionnaires need to be completed by the patient to see if the drug helps them in relieving their symptoms.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Quebec
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Mont St-Hilaire, Quebec, Canada, J3H 6C4
- Axcan Pharma inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients suffering from functional dyspepsia according to Rome II criteria
- 18-65 years old
- Absence of, or infrequent heartburn (one episode per week or less)
- Helicobacter pylori (H. pylori) negative
- Normal upper endoscopy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Symptom relief
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety
|
Impact of symptom relief on quality of life
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicholas Talley, MD, Mayo Clinic, Rochester, Minn
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
- ITOFD04-01
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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