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Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370084
First Posted: August 30, 2006
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Forest Laboratories
  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 Other: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

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

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

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

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.

  Eligibility

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
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
  Contacts and Locations
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


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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00370084     History of Changes
Other Study ID Numbers: ITODG04-01
041026
First Submitted: August 28, 2006
First Posted: August 30, 2006
Last Update Posted: February 9, 2017
Last Verified: February 2017

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