drugset / Trial / NCT00638495
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
RandomizedParallel-groupDouble-blindTreatment
Summary
The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary metabolites are to be determined.
Timeline
- Start
- 2008-03
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nalfurafine | Small molecule | 2.5 ug | Oral |
| Subject | Nalfurafine | Small molecule | 5 ug | Oral |
| Subject | Nalfurafine | Small molecule | 10 ug | Oral |
Indications
No indication recorded.