Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000520033
Ethics application status
Approved
Date submitted
22/06/2010
Date registered
23/06/2010
Date last updated
12/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised placebo controlled crossover trial to evaluate the effects of different doses of taurocholic acid in a suppository on gastrointestinal hormone secretion and appetite in healthy humans.
Scientific title
A randomised placebo controlled crossover trial to evaluate the effects of different doses of taurocholic acid in a suppository on gastrointestinal hormone secretion and appetite in healthy humans.
Secondary ID [1] 252082 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 257628 0
Obesity 257629 0
Condition category
Condition code
Metabolic and Endocrine 257802 257802 0 0
Diabetes
Diet and Nutrition 257804 257804 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each healthy volunteers will undergo four studies (3 with different doses of taurocholic acid 500mg, 1000mg, and 1500mg and one with control), in double-blind, randomised fashion, separated by 3 - 7 days. On each day the test material will be administered as a suppository.
Intervention code [1] 256706 0
Treatment: Drugs
Comparator / control treatment
Suppository containing vehicle only containing no additional component
Control group
Placebo

Outcomes
Primary outcome [1] 258669 0
Plasma concentrations of glucagon-like peptide-1 (GLP-1), Peptide YY (PYY), and oxyntomodulin
Timepoint [1] 258669 0
T= -5, 10, 30, 60, 90, 120, 180 min, where the suppository is administered at T=0 min
Secondary outcome [1] 264664 0
Appetite scores by visual analogue questionnaire
Timepoint [1] 264664 0
T= -5, 10, 30, 60, 90, 120, 180 min, where the suppository is administered at T=0 min
Secondary outcome [2] 264665 0
Food intake from an ad libitum buffet meal
Timepoint [2] 264665 0
Offered over 30 minutes, from 180 - 210 min after the suppository is administered

Eligibility
Key inclusion criteria
Haemoglobin > 135 g/L
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medications affecting gut function
Alcohol intake >20g daily or cigarette smoking
Significant gastrointestinal disease or surgery
Impaired liver or renal function
Blood donation within 3 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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/07/2010
Actual
5/07/2010
Date of last participant enrolment
Anticipated
Actual
8/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257176 0
Government body
Name [1] 257176 0
National Health and Medical Research Council
Country [1] 257176 0
Australia
Funding source category [2] 257177 0
Commercial sector/Industry
Name [2] 257177 0
Satiogen Pharmaceuticals Inc.
Country [2] 257177 0
United States of America
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 256434 0
None
Name [1] 256434 0
Address [1] 256434 0
Country [1] 256434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259215 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 259215 0
Ethics committee country [1] 259215 0
Australia
Date submitted for ethics approval [1] 259215 0
Approval date [1] 259215 0
31/05/2010
Ethics approval number [1] 259215 0
RAH Protocol No. 100514

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31325 0
A/Prof Chris Rayner
Address 31325 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 31325 0
Australia
Phone 31325 0
+61 8 82222916
Fax 31325 0
Email 31325 0
[email protected]
Contact person for public queries
Name 14572 0
A/Prof Chris Rayner
Address 14572 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 14572 0
Australia
Phone 14572 0
+61 8 82222916
Fax 14572 0
+61 8 82233870
Email 14572 0
[email protected]
Contact person for scientific queries
Name 5500 0
A/Prof Chris Rayner
Address 5500 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 5500 0
Australia
Phone 5500 0
+61 8 82222916
Fax 5500 0
+61 8 82233870
Email 5500 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.