None listed
Conditions
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.
Interventions
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 thio
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
Sponsors
Mater Hospital Brisbane
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Pregnant women
Outcome results
None listed