Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000934741
Ethics application status
Approved
Date submitted
9/06/2022
Date registered
30/06/2022
Date last updated
30/06/2022
Date data sharing statement initially provided
30/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Rectal concentrations of thioguanine after enema administration
Scientific title
Tissue concentrations of thioguanine in rectal tissue samples in patients administered thioguanine rectally
Secondary ID [1] 307320 0
Nil known
Universal Trial Number (UTN)
U1111-1279-1171
Trial acronym
Inflammatory Bowel Disease
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral and gastrointestinal 326609 0
Condition category
Condition code
Oral and Gastrointestinal 323853 323853 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will self administer a rectal enema preparation of Pentasa enema 500mg combined with thioguanine 20mg daily for 7 days. This will be followed by a single 5-hour visit to the study clinic during which participants will have a flexible sigmoidoscopy performed by a registered gastroenterologist and rectal biopsies taken to determine tissue thioguanine concentration. Immediately following the flexible sigmoidoscopy, participants will have one further rectal enema with Pentasa and thioguanine and 4 blood samples taken over 4 hours to determine thioguanine concentration.
Adherence will be determined by daily medication record and pill return count.
Intervention code [1] 323765 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331668 0
Thioguanine concentrations in rectal tissue assessed by flexible sigmoidoscopy and rectal biopsies.
Timepoint [1] 331668 0
7 days post intervention
Secondary outcome [1] 410691 0
Plasma thioguanine concentrations for 4 hours after rectal administration, at steady state.
Timepoint [1] 410691 0
4 samples will be taken 7 days post intervention, immediately before the dose and 1, 2, and 4 hours post-final dose

Eligibility
Key inclusion criteria
Patients previously treated with Pentasa/thioguanine enemas for proctitis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Two participants will be enrolled. Analysis will be descriptive for thioguanine concentrations in rectal tissue.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
31/08/2022
Actual
Sample size
Target
2
Accrual to date
Final
Recruitment outside Australia
Country [1] 24829 0
New Zealand
State/province [1] 24829 0

Funding & Sponsors
Funding source category [1] 311613 0
Commercial sector/Industry
Name [1] 311613 0
Douglas Pharmaceuticals Ltd
Country [1] 311613 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Douglas Pharmaceuticals Ltd
Address
2 Te Pai Place, Henderson, Auckland 0610
Country
New Zealand
Secondary sponsor category [1] 313047 0
None
Name [1] 313047 0
Address [1] 313047 0
Country [1] 313047 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311055 0
Northern A Health and Disabilities Ethics Committee
Ethics committee address [1] 311055 0
133 Molesworth Street, Wellington 6011
Ethics committee country [1] 311055 0
New Zealand
Date submitted for ethics approval [1] 311055 0
Approval date [1] 311055 0
27/05/2022
Ethics approval number [1] 311055 0

Summary
Brief summary
A controlled release oral formulation of thioguanine is being developed by Douglas Pharmaceuticals for treatment of IBD. As part of the development program it is planned to measure mucosal tissue concentrations of the drug after administration. This study is to develop the methodology for measuring tissue concentrations of thioguanine in rectal biopsy tissue after thioguanine rectal administration. The patients have previously been treated successfully with thioguanine 20mg dissolved in 50ml of Pentasa enema. Two of these patients will have daily treatment for 7 days before flexible sigmoidoscopy to obtain rectal biopsy samples to measure thioguanine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119838 0
Prof Murray Barclay
Address 119838 0
Barclay Gastroenterology
53 Straven Road, Christchurch 8011
Country 119838 0
New Zealand
Phone 119838 0
+64 272127334
Fax 119838 0
Email 119838 0
murray@barclaygastro.com
Contact person for public queries
Name 119839 0
Prof Murray Barclay
Address 119839 0
Barclay Gastroenterology
53 Straven Road, Christchurch 8011
Country 119839 0
New Zealand
Phone 119839 0
+64 272127334
Fax 119839 0
Email 119839 0
murray@barclaygastro.com
Contact person for scientific queries
Name 119840 0
Prof Murray Barclay
Address 119840 0
Barclay Gastroenterology
53 Straven Road, Christchurch 8011
Country 119840 0
New Zealand
Phone 119840 0
+64 272127334
Fax 119840 0
Email 119840 0
murray@barclaygastro.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study is for commercial development of a new product only


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.