Status:
COMPLETED
The Influence of 5-Aminosalicylates on Thiopurine Metabolite Levels
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Crohn's Disease
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the influence of different 5-aminosalicylate concentrations on the metabolism of azathioprine or 6-mercaptopurine in patients with inflammatory bowel disease.
Detailed Description
Background: The concomitant use of 5-aminosalicylates (5ASA) next to azathioprine (AZA) or 6-mercaptopurine (6MP) in the treatment of inflammatory bowel disease (IBD) may lead to an increased effecti...
Eligibility Criteria
Inclusion
- Adult patients, aged between 18 - 70 years
- Informed consent
- Diagnosis of CD or UC for at least 6 months (histological and endoscopically confirmed)
- Steady state AZA of 6-MP use (an unchanged thiopurine regime for at least 4 weeks)
- Normal liver and kidney function (ALAT / AP / creatinin \< 2 x upper normal limit)
- Quiescent disease (HBI score ≤ 4 for CD or modified TLWI score ≤ 4 for UC)
Exclusion
- Bone marrow suppression (platelets / leucocytes \< 1 x lower normal level)
- Presence of active infection (fever and CRP \> 1 x upper normal limit)
- Anemia (hemoglobin \< 6 mmol)
- Known duodenal Crohn's disease interfering significantly with resorptive area
- Small bowel surgery interfering significantly with resorptive area
- Known intolerance to 5-ASA compounds
- Current use of 5-ASA compounds
- Use of 5-ASA compounds within the last 30 days
- Concomitant use of allopurinol, ACE-inhibitors or furosemide
- Pregnancy, expected pregnancy or lactation within 6 months
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00167882
Start Date
July 1 2005
End Date
August 1 2006
Last Update
September 11 2006
Active Locations (1)
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1
Maasland Hospital
Sittard, Netherlands