The Influence of 5-Aminosalicylates on Thiopurine Metabolite Levels

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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