Trial Details
RecruitingBasic Information
| Clinical ID | c3114 |
|---|---|
| Identifier | ACTRN12613001347752 |
| Trial Title | A randomized controlled trial of patients with IBD attending specialist clinics comparing de novo combination allopurinol and thiopurine versus thiopurine and placebo (ie standard practice) in terms of objective and clinical outcomes at six months |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | Inflammatory Bowel Disease; Inflammatory Bowel Disease;Oral and Gastrointestinal - Inflammatory bowel disease;Inflammatory and Immune System - Other inflammatory or immune system disorders |
| Interventions | De novo combination therapy with allopurinol 100mg orally and gradual pre-specified dose increments of azathioprine (or mercaptopurine) starting at 50mg (or 25mg) orally daily as determined by measuring thiopurine metabolite levels at week 14 and the absence of serious side effects. The decision to commence azathioprine or mercaptopurine will be at the discretion of the treating clinician as per their standard practice. Medications will be supplied in sealed non-distinguishable treatment bottles which will be supplied every eight weeks and drug/ packaging will be returned to assess adherence at the relevant study visit(s). The overall duration of study treatment will be six months. |
Participant Information
| Sponsor | Eastern Health |
|---|---|
| City | - |
| Country/Region | Australia |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT, ELDER, OLDER_ADULT |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | PHASE3|PHASE4 |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | - |