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A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet

Uremic Pruritus Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Multisite Bridging Clinical Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet in the Treatment of Refractory Pruritus in Hemodialysis Patients

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04728984
Study type Interventional
Source Shenyang Sunshine Pharmaceutical Co., LTD.
Contact Chen Jianghua, Master
Phone 0571-87236992
Email chenjianghua@zju.edu.cn
Status Recruiting
Phase Phase 3
Start date September 7, 2020
Completion date October 31, 2021
View Details
See also
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