A Phase 3 interventional study of Itopride Hydrochloride and itopride in Dyspepsia, sponsored by Forest Laboratories. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-08.
Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment
Itopride is a new compound that is 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. They feel full after eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia.
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.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 645 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients suffering from functional dyspepsia according to Rome II criteria
100 mg tid
100 mg three times daily
Symptom relief
Impact of symptom relief on quality of life
Safety
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Forest Laboratories