Ulcerative Colitis Clinical Trial
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.
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 effectiveness of therapy as higher levels of the active metabolite of AZA/6MP
(6-thioguaninenucleotides (6TGNs) are measured.
Objectives:
To determine the influence of 5-ASA compounds and its metabolites on the metabolites of
AZA/6MP (6TGNs + 6-methylmercaptopurine (6MMP).
Methods:
Patients with quiescent disease under AZA/6MP therapy are eligible. Patients will receive
three succeeding regimes (5ASA 2 gram/5ASA 4 gram/ no 5ASA) of 4 weeks next to the standard
AZA/6MP therapy. At the start and at the end of every regime 5ASA and its major metabolite
(N-acetyl-5ASA) will be determined in serum next to the measurement of 6TGNs and 6MMP in
erythrocytes. The safety will monitored by standard laboratory parameters every four weeks.
Population:
Patients with IBD in remission and unchanged AZA/6MP dosages for at least 4 weeks.
Medication:
5ASA (Pentasa ® granules; Ferring) will be administered orally in dosages of 2 or 4 grams
daily for a period of 4 weeks.
Endpoints:
The rise or decrease in 6TGNs and 6MMP during the different 5ASA regimes. The evaluation of
the safety of co-administrating 5ASA next to AZA/6MP.
Risks:
Side effects of 5ASA use are limited and well known. Some case reports have described the
potential risk of developing a myelodepression when AZA/6MP and 5ASA are given together due
to the rise in 6TGNs. However, in daily practice both drugs are administered together
frequently. The risks of the frequent blood draws are minimal and usually self-limiting
(haematoma).
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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