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

NCT04728984 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2021-01-28

No results posted yet for this study

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

Conditions

  • Uremic Pruritus

Interventions

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

Sponsors & Collaborators

  • Shenyang Sunshine Pharmaceutical Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04728984 on ClinicalTrials.gov