Last reviewed · How we verify
Dose-effect Relationship Between Allopurinol, Azathioprine and 6-thioguanine Nucleotide Levels (6-TGN) in Inflammatory Bowel Disease Patients.
Main Study Objectives: The study is conducted to * evaluate the minimal allopurinol and azathioprine doses that, in combination, produce therapeutic 6-TGN levels * evaluate the safety and tolerability of the different allopurinol/azathioprine dose levels * assess if concomitant allopurinol affects TPMT activity * assess the clinical efficacy of concomitant allopurinol-azathioprine therapy in the included patients
Details
| Lead sponsor | University of Zurich |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 6 |
| Start date | 2009-01 |
| Completion | 2011-09 |
Conditions
- Inflammatory Bowel Disease
Interventions
- Azathioprine / Allopurinol
Primary outcomes
- Pharmacokinetics: Quantification of trough concentrations of 6-TGN and 6-MMPN in erythrocytes using HPLC at each dose level. — three times per cycle
Countries
Switzerland