This is a multisite study to evaluate the efficacy, safety and plasma concentration of Nalfurafine Hydrochloride orally disintegrating tablet in the treatment of refractory pruritus in maintenance hemodialysis patients, and to bridge the efficacy data from Japan
This clinical trial is a bridging study. when selecting the subjects, the most appropriate pruritus medication for the subjects was used first.Then, subjects with "existing treatment-resistant" pruritus will continue to receive basic pruritus treatment if the corresponding treatment is not sufficiently effective, and the experimental drug or placebo will be added to this treatment to evaluate the effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
Nalfurafine Hydrochloride 2.5μg\*2 ; Oral administration after dinner, once daily for 14 consecutive days
Nalfurafine Hydrochloride 2.5μg+ A placebo pill; Oral administration after dinner, once daily for 14 consecutive days
two placebo pills; Oral administration after dinner, once daily for 14 consecutive days
The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGVariation in VAS of Nalfurafine Hydrochloride versus Placebo
The Variation = the mean of the daily maximum VAS value during the observation period before administration(D8-14) - the mean of the daily maximum VAS value during the administration period (D25-31). Only the days on which the VAS values were recorded during the day and night were evaluated.
Time frame: up to 38(+1) days
Variation in pruritus scores based on the Hsie-Kawashima pruritus severity assessment method
Pruritus scores were assessed during the observation period before administration(D8-14) and administration period (D25-31), and only the days when pruritus scores were recorded during the day and night were evaluated.
Time frame: up to 38(+1) days
Variation in nocturnal pruritus scores based on the Hsie-Kawashima pruritus severity assessment method (improvement of pruritus-induced sleep disorders).
After calculating the mean values of nocturnal pruritus scores during the observation period before administration(D8-14) and administration period (D25-31), the variation was calculated.
Time frame: up to 38(+1) days
Improvement degree of VAS
The average VAS value of the observation period before administration (D8-14) and the average VAS value of the administration period (D25-31) were calculated, and the improvement degree was determined as very effective, effective and ineffective according to the variation of the average VAS value.
Time frame: up to 38(+1) days
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