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

NCT03101800 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2018-08-15

No results posted yet for this study

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.

Conditions

  • Colitis, Ulcerative
  • Colitis Ulcerative Exacerbation

Interventions

DRUG

Azathioprine and Allopurinol

Low dose Azathioprine in combination with allopurinol 100 mg for 1 year

DRUG

Azathioprine

Standard weight based azathioprine dosage

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Viborg Regional Hospital

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Sydvestjysk Hospital Esbjerg

    collaborator UNKNOWN

  • Hvidovre University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-14
Primary Completion
2019-11-14
Completion
2019-12-14

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03101800 on ClinicalTrials.gov