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Trial registered on ANZCTR


Registration number
ACTRN12624001327572p
Ethics application status
Submitted, not yet approved
Date submitted
13/12/2024
Date registered
13/12/2024
Date last updated
13/12/2024
Date data sharing statement initially provided
13/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
test
Scientific title
test
Secondary ID [1] 313291 0
test
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
test 335615 0
Condition category
Condition code
Cancer 332181 332181 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
test
Intervention code [1] 329865 0
Treatment: Drugs
Comparator / control treatment
test
Control group
Active

Outcomes
Primary outcome [1] 339775 0
test
Timepoint [1] 339775 0
test
Primary outcome [2] 339779 0
test2
Timepoint [2] 339779 0
Primary outcome [3] 339780 0
test2
Timepoint [3] 339780 0
test2
Secondary outcome [1] 441172 0
test
Timepoint [1] 441172 0
test

Eligibility
Key inclusion criteria
test
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
test

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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


Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2024
Actual
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
27/12/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 317740 0
Government body
Name [1] 317740 0
test gov body
Country [1] 317740 0
Australia
Primary sponsor type
Government body
Name
gov body test name
Address
Country
Australia
Secondary sponsor category [1] 320055 0
None
Name [1] 320055 0
Address [1] 320055 0
Country [1] 320055 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316433 0
test
Ethics committee address [1] 316433 0
Ethics committee country [1] 316433 0
Australia
Date submitted for ethics approval [1] 316433 0
12/12/2024
Approval date [1] 316433 0
Ethics approval number [1] 316433 0

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

Contacts
Principal investigator
Name 137870 0
Mr Geoffrey Hall
Address 137870 0
test
Country 137870 0
Australia
Phone 137870 0
+61 411123456
Fax 137870 0
Email 137870 0
[email protected]
Contact person for public queries
Name 137871 0
Geoffrey Hall
Address 137871 0
test
Country 137871 0
Australia
Phone 137871 0
+61 411123456
Fax 137871 0
Email 137871 0
[email protected]
Contact person for scientific queries
Name 137872 0
Geoffrey Hall
Address 137872 0
test
Country 137872 0
Australia
Phone 137872 0
+61 411123456
Fax 137872 0
Email 137872 0
[email protected]

Data sharing statement
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?

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.