NCT00638495

Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Toray Industries, Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pruritus With Chronic Liver Disease

Interventions

Type	Name	Description
DRUG	Nalfurafine Hydrochloride (TRK-820)	TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.
DRUG	Placebo	Placebo is to be administered orally once daily, after supper in principle, for 28 days.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-03-19
• Last updated: 2010-02-01

Locations

1 site across 1 country: Japan