Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001337662p
Ethics application status
Submitted, not yet approved
Date submitted
9/10/2023
Date registered
19/12/2023
Date last updated
19/12/2023
Date data sharing statement initially provided
19/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Rectal and blood concentrations of thioguanine given by suppository in inflammatory bowel disease
Scientific title
Concentrations of Thioguanine and its metabolite 6TGN in Blood and Rectal Tissue Samples in Patients with Refractory Ulcerative Proctitis Administered Thioguanine by Suppository
Secondary ID [1] 310761 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inflammatory Bowel Disease 331719 0
Condition category
Condition code
Oral and Gastrointestinal 328467 328467 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of thioguanine by suppository once daily, 5mg or 20mg as determined by computer randomisation, rectally for 29 days. Adherence monitored by product return, and pharmacokinetics on day 1 and day 29.
Intervention code [1] 327168 0
Treatment: Drugs
Comparator / control treatment
Eight control patients without proctitis will be recruited to obtain colorectal concentrations of thioguanine whilst on azathioprine (2 patients), thioguanine orally (4 patients) or no thiopurine (2 patients).
Control group
Active

Outcomes
Primary outcome [1] 336289 0
Improvement in inflammatory bowel disease symptoms
Timepoint [1] 336289 0
SCCAI at days 1, 8, 15, 22, and 29 post-commencement of thioguanine suppositories.
Primary outcome [2] 336926 0
Improvement in colitis activity determined by endoscopic appearance
Timepoint [2] 336926 0
Day 29
Secondary outcome [1] 427678 0
Pharmacokinetics including AUC, Cmax, Tmax, Clearance and half-life
Timepoint [1] 427678 0
Blood samples drawn at 30 min, 1, 2, 4, and 6 hours post thioguanine suppository administration and days 1 and 29.
Flexible sigmoidoscopy for disease activity by Mayo and UCEIS (ulcerative colitis endoscopic index of severity) scores at baseline and on day 29.

Eligibility
Key inclusion criteria
Patients with refractory ulcerative proctitis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by computer
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/12/2023
Actual
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 25883 0
New Zealand
State/province [1] 25883 0

Funding & Sponsors
Funding source category [1] 314991 0
Commercial sector/Industry
Name [1] 314991 0
Douglas Pharmaceuticals
Country [1] 314991 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Douglas Pharmaceuticals
Address
2 Te Pai Pl Henderson Auckland 0610 New Zealand
Country
New Zealand
Secondary sponsor category [1] 317007 0
None
Name [1] 317007 0
Address [1] 317007 0
Country [1] 317007 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313964 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 313964 0
Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140
Ethics committee country [1] 313964 0
New Zealand
Date submitted for ethics approval [1] 313964 0
18/10/2023
Approval date [1] 313964 0
Ethics approval number [1] 313964 0

Summary
Brief summary
Seven patients with refractory ulcerative proctitis will be given thioguanine by suppository 20mg or 5 mg for 29 days. Efficacy and safety will be assessed but the main objective is to determine rectal tissue concentrations of thioguanine following rectal administration of thioguanine by suppository. Eight control patients without proctitis will be recruited to obtain rectal concentrations whilst on azathioprine, thioguanine orally or no thiopurine.
Secondary objectives include:
• to compare rectal and blood concentrations of 6-TGN after rectal administration with those seen previously after tablet/Pentasa enema administration rectally.
• assessment of signals for efficacy and/or toxicity
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129942 0
Prof Murray Barclay
Address 129942 0
Barclay Gastroenterology, 53 Straven Road, Christchurch 8011
Country 129942 0
New Zealand
Phone 129942 0
+64 272127334
Fax 129942 0
Email 129942 0
murray@barclaygastro.com
Contact person for public queries
Name 129943 0
Prof Murray Barclay
Address 129943 0
Barclay Gastroenterology, 53 Straven Road, Christchurch 8011
Country 129943 0
New Zealand
Phone 129943 0
+64 272127334
Fax 129943 0
Email 129943 0
murray@barclaygastro.com
Contact person for scientific queries
Name 129944 0
Prof Murray Barclay
Address 129944 0
Barclay Gastroenterology, 53 Straven Road, Christchurch 8011
Country 129944 0
New Zealand
Phone 129944 0
+64 272127334
Fax 129944 0
Email 129944 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
The data will belong to Douglas Pharmaceuticals who will make this decision later


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.