Trial Review

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Please note the ANZCTR will be unattended on Monday the 27th of January due to the national public holiday.

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
ACTRN12625000078459p
Ethics application status
Not yet submitted
Date submitted
11/02/2025
Date registered
11/02/2025
Date last updated
11/02/2025
Date data sharing statement initially provided
11/02/2025
Date results provided
11/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Step 11 IPD testing - new form 11022025 - No IPD
Scientific title
Step 11 IPD testing - new form 11022025 - No IPD
Secondary ID [1] 313809 0
Step 11 IPD testing - new form 11022025 - No IPD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Step 11 IPD testing - new form 11022025 - No IPD 336444 0
Condition category
Condition code
Diet and Nutrition 332965 332965 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Intervention code [1] 330397 0
Treatment: Drugs
Comparator / control treatment
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Control group
Dose comparison

Outcomes
Primary outcome [1] 340503 0
Step 11 IPD testing - new form 11022025 - No IPD
Timepoint [1] 340503 0
Step 11 IPD testing - new form 11022025 - No IPD
Secondary outcome [1] 444275 0
Step 11 IPD testing - new form 11022025 - No IPD
Timepoint [1] 444275 0
Step 11 IPD testing - new form 11022025 - No IPD

Eligibility
Key inclusion criteria
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD
Step 11 IPD testing - new form 11022025 - No IPD

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)
Step 11 IPD testing - new form 11022025 - No IPD
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Step 11 IPD testing - new form 11022025 - No IPD
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318276 0
University
Name [1] 318276 0
Step 11 IPD testing - new form 11022025 - No IPD
Country [1] 318276 0
Australia
Primary sponsor type
University
Name
Step 11 IPD testing - new form 11022025 - No IPD
Address
Country
Australia
Secondary sponsor category [1] 320664 0
None
Name [1] 320664 0
Address [1] 320664 0
Country [1] 320664 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316916 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 316916 0
Ethics committee country [1] 316916 0
Australia
Date submitted for ethics approval [1] 316916 0
02/05/2025
Approval date [1] 316916 0
Ethics approval number [1] 316916 0

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

Contacts
Principal investigator
Name 139430 0
Dr Step 11 IPD testing - new form 11022025 - No IPD
Address 139430 0
Step 11 IPD testing - new form 11022025 - No IPD
Country 139430 0
Australia
Phone 139430 0
+61 2 9562 5333
Fax 139430 0
Email 139430 0
[email protected]
Contact person for public queries
Name 139431 0
Step 11 IPD testing - new form 11022025 - No IPD
Address 139431 0
Step 11 IPD testing - new form 11022025 - No IPD
Country 139431 0
Australia
Phone 139431 0
+61 2 9562 5333
Fax 139431 0
Email 139431 0
[email protected]
Contact person for scientific queries
Name 139432 0
Step 11 IPD testing - new form 11022025 - No IPD
Address 139432 0
Step 11 IPD testing - new form 11022025 - No IPD
Country 139432 0
Australia
Phone 139432 0
+61 2 9562 5333
Fax 139432 0
Email 139432 0
[email protected]

Data sharing statement
Will sharing of individual participant data from this study be considered?
No
No IPD sharing reason/comment: Step 11 IPD testing - new form 11022025 - No IPD

Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24485Ethical approval    Step 11 IPD testing - new form 11022025 - No IPD
24486Study protocol    389093-(Uploaded-11-02-2025-16-26-34)-ANZCTR Data field explanation_Jan2024.pdf



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.