Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
chris.rayner@adelaide.edu.au
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
chris.rayner@adelaide.edu.au
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
chris.rayner@adelaide.edu.au

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.