Use of Ajunctive Allopurinol in Azathioprine/6-Mercaptopurine Non-responders to Optimize 6-Thioguanine Nucleotide Production and Improve Clinical Outcomes in Patients with Inflammatory Bowel Disease (IBD).
The Triple A (Adjunctive Allopurinol and Azathioprine) Study: Use of Ajunctive Allopurinol in Azathioprine/6-Mercaptopurine Non-responders to Optimize 6-Thioguanine Nucleotide Production and Improve Clinical Outcomes in Patients with Inflammatory Bowel Disease (IBD).
The Alfred Hospital
78 participants
Apr 7, 2011
Interventional
Conditions
Summary
It is understood that the body metabolizes azathioprine (AZA) to produce two chemical end-products: 6-thioguanine (6-TGN) and 6-methylmercaptopurine (6-MMP). 6-TGN is the chemical that makes these drugs work, while 6-MMP causes side-effects. Our research group has previously shown that by adding another drug, allopurinol, patients who otherwise made 6-MMP switched to instead produce 6-TGN, thereby increasing their response to these drugs. Our proposal is for a clinical trial that aims to confirm the safety and efficacy of this clinical maneuver.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Eligible IBD patients will be randomly allocated to receive either 100mg or 50mg of allopurinol orally in 1:1 using computer generated list. Patients will continue to take their usual azathioprine or 6-mercaptopurine at reduced doses as determined by the study doctor. The study duration for each individual patient is 24 weeks. Allopurinol will be taken once dail and frequency for usual azathioprine or 6-mercaptopurine treatments remains regular.
Locations(1)
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ACTRN12611000363987