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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia
Scientific title
Effects of Itopride Hydrochloride on Gastric Emptying, Glycaemia and "Meal-related" Symptoms in Patients With Type 1 and Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
Secondary ID [2] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Itopride
Other interventions - Placebo

Placebo Comparator: Placebo -

Experimental: Itopride -

Treatment: Drugs: Itopride
oral, three times daily

Other interventions: Placebo
oral, three times daily

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Gastric emptying assessment
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution
Timepoint [1] 0 0

Key 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
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Adelaide, Department of Medicine - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Forest Laboratories

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Michael Horowitz, M.D.
Address 0 0
Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications