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

NCT04728984 | Unknown Phase 3

• 1 other identifier: SYSS-Remitch-HD-III-01
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Variation 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.

  up to 38(+1) days

Secondary Outcomes (3)

• Variation in pruritus scores based on the Hsie-Kawashima pruritus severity assessment method

  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).

  up to 38(+1) days

• Improvement degree of VAS

  up to 38(+1) days

Study Arms (3)

Nalfurafine Hydrochloride 5μg

EXPERIMENTAL

Oral administration after dinner, once daily for 14 consecutive days

Drug: Nalfurafine Hydrochloride

Nalfurafine Hydrochloride 2.5μg

EXPERIMENTAL

Oral administration after dinner, once daily for 14 consecutive days

Drug: Nalfurafine Hydrochloride+Placebo

Placebo

PLACEBO COMPARATOR

Oral administration after dinner, once daily for 14 consecutive days

Drug: Placebo

Interventions

Nalfurafine Hydrochloride DRUG

Nalfurafine Hydrochloride 2.5μg\*2 ; Oral administration after dinner, once daily for 14 consecutive days

Nalfurafine Hydrochloride 5μg

Nalfurafine Hydrochloride+Placebo DRUG

Nalfurafine Hydrochloride 2.5μg+ A placebo pill; Oral administration after dinner, once daily for 14 consecutive days

Nalfurafine Hydrochloride 2.5μg

Placebo DRUG

two placebo pills; Oral administration after dinner, once daily for 14 consecutive days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic renal failure patients who have been on stable dialysis for 3 months or more, receive regular hemodialysis 3 times a week, and expect no significant treatment changes or dramatic changes in their condition during the clinical trial;
• In the 1 year prior to signing the informed consent, patients who were treated with the following drugs A and/or B: (A) Systematic treatment (oral, injection, etc.) of "prescribed drugs for pruritus" (including antihistamines or antiallergic drugs) for more than 2 weeks consecutively; (B). Use of " prescribed drugs for pruritus" (ointments, etc.) or topical treatment of moisturizers prescribed by physicians;
• When signing the informed consent, the patient is older than 18 years old (including 18 years old), regardless of gender;
• During the observation period before administration (D8-14), the number of days for which the VAS values were measured at the time of getting up and going to bed should not be less than 5 days, and the average value of the larger VAS values in the morning and evening measurements should not be less than 50 mm;
• During the observation period before administration (D8-14), The number of days in which the larger VAS value measured in the morning and evening measurements (if there was a missing time in getting up or going to bed, the value which has been measured was selected) is not less than 20 mm, was not less than 5 days;
• During the observation period before administration (D8-14), the number of days in which the pruritus severity of Hsie-Kawashima's was evaluated at the time of getting up and at the time of going to bed was not less than 5 days, in which the maximum of the pruritus score was not less than 3 (moderate) in the morning and evening measurements was more than half.

You may not qualify if:

• Malignant tumor patients;
• Patients with mental illness or mental retardation who cannot correctly understand the VAS score and describe their feelings;
• Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST) or glutamine transferase (GGT) or total bilirubin higher than twice the upper limit of normal value (ULN) at the screening stage;
• Patients currently suffering from atopic dermatitis or chronic urticaria;
• Patients allergic to opioids;
• Patients with drug or alcohol dependence;
• Patients who had received light therapy for pruritus within 1 month prior to signing the informed consent;
• Patients who have participated in a previous clinical study of Nalfurafine Hydrochloride and have taken Nalfurafine Hydrochloride, or who have participated in this clinical study and have been officially enrolled;
• Participated in other clinical studies (including research drugs and medical devices) within 1 month before signing the informed consent;
• Pregnant women, lactating women, women who have a positive pregnancy test or who do not agree to use contraception during the study period;
• Patients who, as determined by the investigator, could not have their VAS score recorded by themselves for any reason;
• Patients whose comorbidities or previous medical history, as determined by the investigator, would affect the evaluation of this clinical study;
• After testing, human immunodeficiency virus antibody positive;
• Other patients judged by the investigator to be unsuitable for participation in this clinical study.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

The First Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Interventions

TRK 820

Central Study Contacts

Chen Jianghua, Master

CONTACT

0571-87236992; chenjianghua@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 28, 2021
• Study Start: September 7, 2020
• Primary Completion: June 30, 2021
• Study Completion: October 31, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)