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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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. Due 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 three times daily) and placebo on gastric motor and sensory functions in healthy volunteers.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Axcan Pharma; Forest Laboratories

Criteria

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:

1. Patients who have any gastrointestinal symptoms. Do not fulfill the criteria for the irritable bowel syndrome or functional dyspepsia clinically

2. 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

3. Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, caesarian section or tubal ligation

4. Positive symptoms on an abridged bowel disease questionnaire

5. Use of medications that may alter gastrointestinal motility including metoclopramide, domperidone, tegaserod; acetaminophen and ibuprofen will be allowed

6. Current use of medications which may interact with the study medications

7. Patients who have taken any investigational medications within the past 30 days

8. Over the counter medication (except multivitamins) within 7 days of the study

9. Chronic gastrointestinal illness or any systemic disease that could affect gastrointestinal motility for controls

10. Known intolerance or allergy to eggs, milk and Ensure

11. History of chronic diarrhea