drugset / Trial / NCT00113503
Imuran Dosing in Crohn's Disease Study
Phase 2
Terminated
50 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Prometheus Laboratories · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will compare two different dosing methods of azathioprine (IMURAN) in participants with Crohn's disease who are currently taking steroids (e.g. prednisone or budesonide)or who have just started steroids. The study can be up to 54 weeks long. All participants enrolled will receive active drug. Participants will take doses either based upon weight or based on the patient's ability to breakdown the drug (monitored by 6-thioguanine nucleotides (6-TGN) metabolite levels in the blood). All patients enrolled in the study will receive active study drug.
Timeline
- Start
- 2005-07
- Primary completion
- 2007-12
- Completion
- 2007-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azathioprine | Small molecule | 1 mg/kg | — |
| Comparator | Azathioprine | Small molecule | 2.5 mg/kg | — |
| Comparator | Azathioprine | Small molecule | 4 mg/kg | — |