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Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

Primary Purpose

Gastroparesis

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Itopride
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Adelaide, Department of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Itopride

Arm Description

Outcomes

Primary Outcome Measures

Gastric emptying assessment

Secondary Outcome Measures

Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution

Full Information

First Posted
August 28, 2006
Last Updated
February 7, 2017
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00370084
Brief Title
Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia
Official Title
Effects of Itopride Hydrochloride on Gastric Emptying, Glycaemia and "Meal-related" Symptoms in Patients With Type 1 and Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Itopride
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Itopride
Intervention Description
oral, three times daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
oral, three times daily
Primary Outcome Measure Information:
Title
Gastric emptying assessment
Time Frame
weekly
Secondary Outcome Measure Information:
Title
Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution
Time Frame
weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Horowitz, M.D.
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Adelaide, Department of Medicine
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia

12. IPD Sharing Statement

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Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

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