Trial Details
Not RecruitingBasic 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 | - |