Status:
COMPLETED
Effects of Itopride on Gastric Motor and Sensory Functions in Healthy Volunteers
Lead Sponsor:
Forest Laboratories
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 inade...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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).
- No history suggestive of small bowel obstruction
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00370110
Start Date
August 1 2005
End Date
November 1 2005
Last Update
February 9 2017
Active Locations (1)
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1
Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905