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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Page 1 of 1 (1 locations)

1

University of Adelaide, Department of Medicine

Adelaide, South Australia, Australia, 5000

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