Status:
COMPLETED
Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia
Lead Sponsor:
Forest Laboratories
Conditions:
Gastroparesis
Eligibility:
All Genders
18-65 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
This is a mechanistic study evaluating in a cross-over design the effects of Itopride hydrochloride. The primary objective of this study is to evaluate the acute effects of itopride hydrochloride (20...
Eligibility Criteria
Inclusion
- Type-1 and Type-2 diabetic patients
- 18 to 65 years old
- Glycated haemoglobin level (HbA1c) below 9%
- Body mass index (BMI) between 18 and 35 kg/m2
Exclusion
- Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g. prokinetic drugs, macrolide antibiotics)
- Exposure to radiation for research purposes during the previous 12 months
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00370084
Start Date
March 1 2005
End Date
July 1 2006
Last Update
February 9 2017
Active Locations (1)
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1
University of Adelaide, Department of Medicine
Adelaide, South Australia, Australia, 5000