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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00370084