The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
269
SK-1405 high dose is to be administered orally once daily for 2 weeks
SK-1405 low dose is to be administered orally once daily for 2 weeks
Placebo is to be administered orally once daily for 2 weeks
Investigational site (there may be other sites in this country)
Tokyo, Japan
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Time frame: 2 weeks
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Time frame: 1 week, 3 weeks
Change from baseline in Itch Severity Assessment
Time frame: 1 week, 2 weeks, 3 weeks
Change from baseline in Sleep Quality Assessment
Time frame: 1 week, 2 weeks, 3 weeks
Change from baseline in 5D Itch Scale
Time frame: 2 weeks
Number of Participants with Adverse Events
Time frame: 5 weeks
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