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Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

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ClinicalTrials.gov Identifier: NCT00370084
Recruitment Status : Completed
First Posted : August 30, 2006
Last Update Posted : February 9, 2017
Information provided by (Responsible Party):
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: Itopride Other: Placebo Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2005
Primary Completion Date : May 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
oral, three times daily
Experimental: Itopride Drug: Itopride
oral, three times daily

Primary Outcome Measures :
  1. Gastric emptying assessment [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution [ Time Frame: weekly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370084

Australia, South Australia
University of Adelaide, Department of Medicine
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Forest Laboratories
Principal Investigator: Michael Horowitz, M.D. Royal Adelaide Hospital

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00370084     History of Changes
Other Study ID Numbers: ITODG04-01
First Posted: August 30, 2006    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms