Trial Details

Recruiting
Basic 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 -