Phase
Condition
Rash
Skin Wounds
Hives (Urticaria)
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females aged 18-65 (inclusive);
Weight (> 50 kg);
Patients with end-stage renal disease receiving hemodialysis (including hemodialysisand hemofiltration) three times a week for at least 3 months.
VAS≥4 at screening
Exclusion
Exclusion Criteria:
New York cardiac function classification (NYHA) ≥ level III in the current or previous 6 months;
Pruritus caused by other than end-stage renal disease or its complications..
History of malignancy
Any physical or mental illness or condition, as determined by the study investigator,that may increase the risk of participating the trial, affect the subject's compliancewith the protocol, or affect the subject's completion of the trial
Positive urine drug screening; Or a history of drug abuse;
Urine test positive for nicotine;
Alcohol breath test positive;
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or transglutaminase (GGT) was 1.5 times higher than the upper limit of normal value (ULN), or totalbilirubin was 1.5 times higher than the upper limit of normal value (ULN);
Screening for hepatitis c antibody (HCVAb), syphilis antibody or humanimmunodeficiency virus (HIV) antibody positive; Or hepatitis B is active;
Abnormal electrocardiogram considered inappropriate to participate in this study bythe investigator
positive for human chorionic gonadotropin (hCG) blood test
A history of allergies to opioids
Has used opioids within one week prior to the current visit, or cannot avoid to useopioids other than the study drug during the study period;
Change the treatment regimen for pruritus within 14 days, or cannot avoid to changethe treatment regimen for pruritus during the study period
Received Ultraviolet phototherapy within 14 days before screening visit; Or cannotavoid to receive ultraviolet light therapy during the study.
Change the treatment regimen of gabapentin, pregabalin, or duloxetine within 14 daysbefore screening visit; Or the treatment regimen of gabapentin, pregabalin, orduloxetine cannot be avoided to be changed during the study period.
Change the treatment regimen of medications within 14 days that may affect thejudgment of antipruritic effect; Or the treatment regimen cannot be avoided to bechanged during the study
Using topical antipruritic drugs, such as creams and patches with moisturizing orantipruritic effects at present.
Kidney transplantation is expected during the study period;
Subjects who had Participated in this trial (defined by signing the informed consent);
Subjects who had Participated in clinical trials of any other drugs within theprevious 3 months; Or plan to participate in other drug trials during the trialperiod;
Subjects who had Participated in the clinical trial of any medical device within theprevious 3 months; Or participate in other medical device tests during the trialperiod.
Study Design
Connect with a study center
The first affiliated hospital of sun yat-sen university
Guangzhou,
ChinaActive - Recruiting
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