drugset / Trial / NCT01094613
Multicenter Clinical Efficacy and Safety Study of Delayed Release 6MP in Crohn's Disease
RandomizedParallel-groupTriple-blindTreatment
Summary
The study is designed to evaluate the clinical efficacy and safety of daily treatment for 12 weeks of oral administration of a delayed release, locally delivered 6MP (mercaptopurine) drug (80 mg), as compared to standard Purinethol (at a dose of 1-1.5 mg/kg/body weight), in alleviating the clinical, immunological and mucosal signs and symptoms of moderately active Crohn's Disease
Timeline
- Start
- 2010-11
- Primary completion
- 2012-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | MERCAPTOPURINE ANHYDROUS | Small molecule | 1 mg/kg | Oral |
| Comparator | MERCAPTOPURINE ANHYDROUS | Small molecule | 1.5 mg/kg | Oral |
| Comparator | MERCAPTOPURINE ANHYDROUS | Small molecule | 50 mg | Oral |
| Comparator | MERCAPTOPURINE ANHYDROUS | Small molecule | 75 mg | Oral |
| Comparator | MERCAPTOPURINE ANHYDROUS | Small molecule | 80 mg | Oral |
| Comparator | MERCAPTOPURINE ANHYDROUS | Small molecule | 100 mg | Oral |
| Comparator | MERCAPTOPURINE ANHYDROUS | Small molecule | 125 mg | Oral |
| Comparator | MERCAPTOPURINE ANHYDROUS | Small molecule | 150 mg | Oral |