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NCT Number: NCT00370084

Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

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.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Adelaide, Department of Medicine

Adelaide, South Australia, 5000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Itopride

Drug

oral, three times daily

Placebo

Other

oral, three times daily

Primary outcomes

  1. Gastric emptying assessment

    Time frame: weekly

Secondary outcomes

  1. Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution

    Time frame: weekly

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

Effects of Itopride Hydrochloride on Gastric Emptying, Glycaemia and "Meal-related" Symptoms in Patients With Type 1 and Type 2 Diabetes Mellitus

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 30, 2006
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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