NCT03101800

Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative Colitis

Low-dose Azathioprine and Allopurinol- Versus Azathioprine Monotherapy in Patients With Ulcerative Colitis: An Investigator-initiated, Open, Multicentre, Parallel-arm, Randomised Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Azathioprine is considered first line immunomodulatory therapy for patients with ulcerative colitis. Up to 50% are treatment failures or experience adverse events leading to treatment withdrawal. Recent evidence suggests that the combination of allopurinol and low dose azathioprine increases the proportion of treatment responders and reduce the risk of adverse events. Objectives: To evaluate the beneficial and harmful effects of low dose azathioprine and allopurinol versus standard azathioprine monotherapy in patients with ulcerative colitis.

Detailed description

Investigator initiated, multicentre, parallel arm, open, randomised controlled trial with blinded assessment

Conditions

• Colitis, Ulcerative
• Colitis Ulcerative Exacerbation

Interventions

Type	Name	Description
DRUG	Azathioprine and Allopurinol	Low dose Azathioprine in combination with allopurinol 100 mg for 1 year
DRUG	Azathioprine	Standard weight based azathioprine dosage

Timeline

• Start date: 2016-12-14
• Primary completion: 2019-11-14
• Completion: 2019-12-14
• First posted: 2017-04-05
• Last updated: 2018-08-15

Locations

1 site across 1 country: Denmark