NCT04728984

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Uremic Pruritus

Interventions

Type	Name	Description
DRUG	Nalfurafine Hydrochloride	Nalfurafine Hydrochloride 2.5μg\*2 ; Oral administration after dinner, once daily for 14 consecutive days
DRUG	Nalfurafine Hydrochloride+Placebo	Nalfurafine Hydrochloride 2.5μg+ A placebo pill; Oral administration after dinner, once daily for 14 consecutive days
DRUG	Placebo	two placebo pills; Oral administration after dinner, once daily for 14 consecutive days

Timeline

• Start date: 2020-09-07
• Primary completion: 2021-06-30
• Completion: 2021-10-31
• First posted: 2021-01-28
• Last updated: 2021-01-28

Locations

1 site across 1 country: China