Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000602426
Ethics application status
Approved
Date submitted
17/04/2016
Date registered
10/05/2016
Date last updated
10/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Thioguanine Suppositories For Proctitis
Scientific title
Thioguanine Suppositories For Proctitis. An Open Label Phase I Study To Evaluate the Efficacy and Safety of TG as a suppository
Secondary ID [1] 289010 0
nil known
Universal Trial Number (UTN)
U1111-1181-9380
Trial acronym
The SUPPO Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inflammatory bowel disease (IBD) 298416 0
proctitis 298417 0
Condition category
Condition code
Oral and Gastrointestinal 298514 298514 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall aim of the current study is to evaluate the safety and efficacy of low dose thioguanine 20mg suppositories in an open-label phase I study involving up to 10 patients with severe proctitis, who are unresponsive to the current standard of care treatments.
Patients will be prescribed one of the below 3 treatments in ascending dose
1. Twice weekly thioguanine rectal suppository 20mg for 28 days (8 supp)
2. 2nd daily thioguanine rectal suppository 20mg for 28 days (14 supp)
3. Daily thioguanine rectal suppository 20mg for 28 days (28 supp)
Adherence will be assessed by interview, return of medication and therapeutic drug monitoring
Intervention code [1] 294493 0
Treatment: Drugs
Comparator / control treatment
Dose comparison will be made between all three treatment groups
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298009 0
Clinical : Partial Mayo score comprising composite rectal bleeding, global physician and bowel frequency subscores
The quality of response will be assessed in two ways -
1. by a fall in partial Mayo score at 2 weeks and sustained at 4 weeks;
2. a fall of partial Mayo score greater than or equal 2 points from baseline at V4
Timepoint [1] 298009 0
at baseline then at 2, 4 weeks post commencement of intervention
Primary outcome [2] 298125 0
Faecal calprotectin laboratory measurement.
The response will be assessed objectively by a fall in faecal calprotectin from baseline
Timepoint [2] 298125 0
at baseline (time 0) and at 4 weeks post commencement of intervention
Secondary outcome [1] 322887 0
Adverse Events/Serious Adverse Events will be assessed by history, physical examination and appropriate blood tests or other tests if indicated by history of physical examination
Timepoint [1] 322887 0
at 2, 4 weeks post commencement of intervention
Secondary outcome [2] 323230 0
Changes to serum C-reactive protein levels from the baseline (0)
Timepoint [2] 323230 0
at baseline then at 2,4 weeks post commencement of intervention

Eligibility
Key inclusion criteria
1. Patients to include in the study will be screened from:
a. Patients attending Gastroenterology outpatient clinics.
b. Pre-existing clinical databases in the department of Gastroenterology and Dr Florin’s private rooms at Mater Health Services, South Brisbane.

2. All patients satisfying the criteria for severe proctitis will be screened and will need to meet the below inclusion and exclusion criteria.
a) Able to give informed consent
b) Age 18 and above
c) Clinical evidence of severe proctitis: Established diagnosis of severe Proctitis (isolated proctitis proven at a colonoscopy within 3 months of consenting and with Mayo endoscopic subscore greater than or equal to 2.)
AND
d) patients who have failed the ‘standard’ combination of oral and rectal 5-ASA at the time of the consenting process as demonstrated by a partial Mayo Score greater than 3 while on standard treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women

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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
ascending dose = first 3 participants allocated to the 'twice weekly' group, the next 3 allocated to the 'every two days' group, and the next 4 allocated to the 'daily' group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All patients will continue their oral 5ASA treatments. Patients will be prescribed one of 3 treatments in an ascending dose order (20mg twice weekly, 20mg every second day, 20mg daily) after confirming safety at each level
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is an exploratory study no formal sample size has been calculated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2016
Actual
Date of last participant enrolment
Anticipated
1/10/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5631 0
Mater Adult Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 293378 0
Self funded/Unfunded
Name [1] 293378 0
Prof Tim Florin
Country [1] 293378 0
Australia
Primary sponsor type
Hospital
Name
Mater Hospital Brisbane
Address
Raymond Terrace
South Brisbane 4101
QLD
Country
Australia
Secondary sponsor category [1] 292194 0
None
Name [1] 292194 0
Address [1] 292194 0
Country [1] 292194 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294835 0
Mater Health Services HREC
Ethics committee address [1] 294835 0
Raymond Terrace
South Brisbane 4101
QLD
Ethics committee country [1] 294835 0
Australia
Date submitted for ethics approval [1] 294835 0
Approval date [1] 294835 0
07/04/2016
Ethics approval number [1] 294835 0
HREC/16/MHS/5

Summary
Brief summary
HYPOTHESES:
1. Topical thioguanine (TG) will improve proctitis as demonstrated by a fall in partial Mayo score

DESIGN
The study will be Phase 1 open label, observational single centre study assessing the efficacy and safety of TG as a suppository.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65186 0
Prof Tim Florin
Address 65186 0
Level 3
Mater Private Clinic
550 Stanley Street
South Brisbane
QLD 4101
Country 65186 0
Australia
Phone 65186 0
+61412764379
Fax 65186 0
Email 65186 0
[email protected]
Contact person for public queries
Name 65187 0
Prof Timothy H Florin
Address 65187 0
Level 3
Mater Private Clinic
550 Stanley Street
South Brisbane
QLD 4101
Country 65187 0
Australia
Phone 65187 0
+61412764379
Fax 65187 0
Email 65187 0
[email protected]
Contact person for scientific queries
Name 65188 0
Prof Timothy H Florin
Address 65188 0
Level 3
Mater Private Clinic
550 Stanley Street
South Brisbane
QLD 4101
Country 65188 0
Australia
Phone 65188 0
+61412764379
Fax 65188 0
Email 65188 0
[email protected]

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.