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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.
Placebo is to be administered orally once daily, after supper in principle, for 28 days.
Toray Industries, Inc
Urayasu, Chiba, Japan
Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week])
Time frame: 4 weeks
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