- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04728984
A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet
January 26, 2021 updated by: Shenyang Sunshine Pharmaceutical Co., LTD.
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
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
135
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chen Jianghua, Master
- Phone Number: 0571-87236992
- Email: chenjianghua@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- Recruiting
- The first affiliated hospital of medical college of zhejiang university
-
Contact:
- Chen Jianghua, Master
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- Patients who had received treatment in inclusion criteria (2) but did not respond;
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Nalfurafine Hydrochloride 5μg
Oral administration after dinner, once daily for 14 consecutive days
|
Nalfurafine Hydrochloride 2.5μg*2 ; Oral administration after dinner, once daily for 14 consecutive days |
EXPERIMENTAL: Nalfurafine Hydrochloride 2.5μg
Oral administration after dinner, once daily for 14 consecutive days
|
Nalfurafine Hydrochloride 2.5μg+ A placebo pill; Oral administration after dinner, once daily for 14 consecutive days
|
PLACEBO_COMPARATOR: Placebo
Oral administration after dinner, once daily for 14 consecutive days
|
two placebo pills; Oral administration after dinner, once daily for 14 consecutive days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation in VAS of Nalfurafine Hydrochloride versus Placebo
Time Frame: up to 38(+1) days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation in pruritus scores based on the Hsie-Kawashima pruritus severity assessment method
Time Frame: up to 38(+1) days
|
Pruritus scores were assessed during the observation period before administration(D8-14) and administration period (D25-31), and only the days when pruritus scores were recorded during the day and night were evaluated.
|
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).
Time Frame: up to 38(+1) days
|
After calculating the mean values of nocturnal pruritus scores during the observation period before administration(D8-14) and administration period (D25-31), the variation was calculated.
|
up to 38(+1) days
|
Improvement degree of VAS
Time Frame: up to 38(+1) days
|
The average VAS value of the observation period before administration (D8-14) and the average VAS value of the administration period (D25-31) were calculated, and the improvement degree was determined as very effective, effective and ineffective according to the variation of the average VAS value.
|
up to 38(+1) days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 7, 2020
Primary Completion (ANTICIPATED)
June 30, 2021
Study Completion (ANTICIPATED)
October 31, 2021
Study Registration Dates
First Submitted
January 26, 2021
First Submitted That Met QC Criteria
January 26, 2021
First Posted (ACTUAL)
January 28, 2021
Study Record Updates
Last Update Posted (ACTUAL)
January 28, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSS-Remitch-HD-III-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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