CompletedPhase 3Phase 4ACTRN12611000363987

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).


Sponsor

The Alfred Hospital

Enrollment

78 participants

Start Date

Apr 7, 2011

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding allopurinol to thiopurine therapy (azathioprine or 6-mercaptopurine) can improve outcomes in inflammatory bowel disease patients who are not responding well to standard dosing. The combination aims to shift how the body processes these medications to produce more of the active therapeutic compound and less of the potentially toxic byproduct.

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

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)

Christchurch, New Zealand

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