Trial Details

Not Recruiting
Basic Information
Clinical ID c2276
Identifier ACTRN12622000934741
Trial Title Tissue concentrations of thioguanine in rectal tissue samples in patients administered thioguanine rectally
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Oral and gastrointestinal; Oral and gastrointestinal;Oral and Gastrointestinal - Inflammatory bowel disease
Interventions 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.
Participant Information
Sponsor Douglas Pharmaceuticals Ltd
City -
Country/Region New Zealand
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Interventional
Phase EARLY_PHASE1
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -