Effects of Itopride on Gastric Motor and Sensory Functions in Healthy Volunteers

In order to compare the effects of two itopride doses (100 mg and 200 mg three times daily) 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.

Inclusion criteria

1.Non-pregnant, non-breastfeeding females 2.18 years of age or older 3.Body mass index between 20 and 32 kg/m2 4.No alarm indicators on clinical assessment (weight loss of more than 7 kg, bleeding, recent recurrent vomiting, progressive dysphagia).

5.No history suggestive of small bowel obstruction

Exclusion criteria

• Patients who have any gastrointestinal symptoms. Do not fulfill the criteria for the irritable bowel syndrome or functional dyspepsia clinically
• Patients with a clinical diagnosis of gastroparesis or an alternative underlying disease that could be responsible for disturbed gastric function e.g. diabetes, post-vagotomy, post-fundoplication
• Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, caesarian section or tubal ligation
• Positive symptoms on an abridged bowel disease questionnaire
• Use of medications that may alter gastrointestinal motility including metoclopramide, domperidone, tegaserod; acetaminophen and ibuprofen will be allowed
• Current use of medications which may interact with the study medications
• Patients who have taken any investigational medications within the past 30 days
• Over the counter medication (except multivitamins) within 7 days of the study
• Chronic gastrointestinal illness or any systemic disease that could affect gastrointestinal motility for controls
• Known intolerance or allergy to eggs, milk and Ensure
• History of chronic diarrhea