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Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

This study has been completed.
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00370084
First received: August 28, 2006
Last updated: December 19, 2008
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastroparesis
 Drug: Itopride Hydrochloride (prokinetic)
Drug: Itopride
Other: placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Itopride Hydrochloride on Gastric Emptying, Glycaemia and "Meal-Related" Symptoms in Patients With Type 1 and Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:
  • Gastric empyting assessment [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemia, relief of upper gastrointestinal symptoms,intragastric meal distribution [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: March 2005
Study Completion Date: July 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Other: placebo
oral tid
Experimental: 2
Itopride
 Drug: Itopride Hydrochloride (prokinetic)
oral , tid
Drug: Itopride
oral, tid

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 tid) 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (eg prokinetic drugs, macrolide antibiotics)
  • Exposure to radiation for research purposes during the previous 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370084

Locations
Australia, South Australia
University of Adelaide, Department of Medicine
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Axcan Pharma
Investigators
Principal Investigator: Michael Horowitz, M.D. Royal Adelaide Hospital
  More Information

No publications provided

Responsible Party: Monique Giguère, Axcan Pharma inc.
ClinicalTrials.gov Identifier: NCT00370084     History of Changes
Other Study ID Numbers: ITODG04-01, 041026
Study First Received: August 28, 2006
Last Updated: December 19, 2008
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Gastroparesis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013