A Phase 3 interventional study of Itopride in Dyspepsia, sponsored by Forest Laboratories. Completed. 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 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.
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.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 466 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.
Exclusion Criteria:
Long-term safety
Time frame: every 2 months
Long-term relief of symptoms
Time frame: every 2 months
No study locations are listed for this record.
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