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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00370084




Registration number
NCT00370084
Ethics application status
Date submitted
28/08/2006
Date registered
30/08/2006
Date last updated
9/02/2017

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
041026
Secondary ID [2] 0 0
ITODG04-01
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

Intervention/exposure
Study type
Interventional
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

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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Crossover
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2006
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
SA
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
Name
Forest Laboratories
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00370084
Trial related presentations / publications
Public notes

Contacts
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