Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
247
Research Site
Multiple Locations, Japan
Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period
The primary analysis was performed using an MMRM with change from baseline in the mean NRS score at each time point as an objective variable; treatment group, time point, and treatment group-by-time point interaction as fixed effects; baseline mean NRS score and dynamic allocation factors, presence of prior treatment with nalfurafine hydrochloride, and presence of specific signs or symptoms to be confirmed in the screening period, as covariates; and subject as a random effect. Looking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.
Time frame: 8 weeks
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