Trial Details

Not Recruiting
Basic Information
Clinical ID c2939
Identifier ACTRN12616000602426
Trial Title Thioguanine Suppositories For Proctitis. An Open Label Phase I Study To Evaluate the Efficacy and Safety of TG as a suppository
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions inflammatory bowel disease (IBD);proctitis; inflammatory bowel disease (IBD) proctitis;Oral and Gastrointestinal - Inflammatory bowel disease
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 dose1. 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
Participant Information
Sponsor Mater Hospital Brisbane
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Interventional
Phase PHASE1
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -