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NCT00370084 Clinical Trial

Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

Gastroparesis Clinical Trial

Official title:
Effects of Itopride Hydrochloride on Gastric Emptying, Glycaemia and "Meal-related" Symptoms in Patients With Type 1 and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00370084
Other study ID # ITODG04-01
Secondary ID 041026
Status Completed
Phase Phase 1/Phase 2
First received August 28, 2006
Last updated February 7, 2017
Start date March 2005
Est. completion date July 2006

Study information
Verified date February 2017
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. The goal of this study is to evaluate the effects of Itopride on gastric motor function and glycemia in patients with diabetes.

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 (200 mg three times daily) on gastric emptying of solid and liquid meal components in patients with type 1 and type 2 diabetes mellitus. Secondary objectives are to evaluate the effects of itopride hydrochloride on the glycaemic response to a meal, "meal-related" upper gastrointestinal symptoms and intragastric meal distribution.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date July 2006
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Itopride
oral, three times daily
Other:
• Placebo
oral, three times daily

Locations
Country Name City State
Australia University of Adelaide, Department of Medicine Adelaide South Australia

Sponsors (1)
Lead Sponsor Collaborator
Forest Laboratories

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastric emptying assessment weekly
Secondary Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution weekly
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