drugset / Trial / NCT00113503

Imuran Dosing in Crohn's Disease Study

NCT00113503

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

EvaluationDrugModalityDoseRoute
Comparator Azathioprine Small molecule 1 mg/kg
Comparator Azathioprine Small molecule 2.5 mg/kg
Comparator Azathioprine Small molecule 4 mg/kg

Indications