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drugset / Trial / NCT04728984

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

NCT04728984 ↗

Phase 3 Unknown 135 enrolled Shenyang Sunshine Pharmaceutical Co., LTD.
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2020-09-07
Primary completion
2021-06-30
Completion
2021-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nalfurafine Small molecule 2.5 ug Oral
Subject Nalfurafine Small molecule 5 ug Oral

Indications

No indication recorded.