Effects of Itopride on Gastric Motor and Sensory Functions in Healthy Volunteers
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 associated with gastroparesis. Do to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. This is a randomized, parallel group, two dose double blind, placebo-controlled study evaluating the effects of itopride (100 mg and 200 mg tid) and placebo on gastric motor and sensory functions in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled, Single Center, Parallel Group Study to Evaluate the Effects of Itopride(100 mg and 200 mg t.i.d.) on Gastric Motor and Sensory Functions in Healthy Volunteers|
- Gastric emptying [ Time Frame: one week ] [ Designated as safety issue: No ]
- Small bowel transit [ Time Frame: one week ] [ Designated as safety issue: No ]
- Gastric accommodation [ Time Frame: one week ] [ Designated as safety issue: No ]
- Postprandial symptoms [ Time Frame: one week ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
In order to compare the effects of two itopride doses (100 mg and 200 mg tid) and placebo on gastric emptying and small bowel transit, gastric accommodation, and postprandial symptoms in female and male healthy volunteers, the following methods, which have been extensively used and validated in the laboratory, will be used:
Scintigraphic gastric emptying of solids and small bowel transit; single photon emission computed tomography to measure gastric accommodation; and the nutrient drink test to measure maximum tolerated volume and postprandial symptoms.
Based on data acquired using the same methods in the laboratory, the sample size of 15 subjects per group provides 80% power to detect an effect size of 16% in the primary endpoint of the study, that is a change in gastric volume (postprandial - fasting). This magnitude of change is considered clinically relevant.
|United States, Minnesota|
|Mayo Clinic College of Medicine|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Nicholas J. Talley, M.D., Ph.D.||Mayo Clinic College of Medicine|