Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

NCT ID: NCT00370084

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Gastroparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

oral, three times daily

Itopride

Group Type EXPERIMENTAL

Itopride

Intervention Type DRUG

oral, three times daily

Interventions

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Itopride

oral, three times daily

Intervention Type DRUG

Placebo

oral, three times daily

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Horowitz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Royal Adelaide Hospital

Locations

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University of Adelaide, Department of Medicine

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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041026

Identifier Type: -

Identifier Source: secondary_id

ITODG04-01

Identifier Type: -

Identifier Source: org_study_id

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