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Opioid Receptor Agonist

Nalfurafine Hydrochloride 5μg for Uremic Pruritus

Phase 3
Waitlist Available
Research Sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 38(+1) days
Awards & highlights

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

Eligible Conditions
  • Uremic Pruritus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 38(+1) days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 38(+1) days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Variation in VAS of Nalfurafine Hydrochloride versus Placebo
Secondary outcome measures
Improvement degree of VAS
Variation in nocturnal pruritus scores based on the Hsie-Kawashima pruritus severity assessment method (improvement of pruritus-induced sleep disorders).
Variation in pruritus scores based on the Hsie-Kawashima pruritus severity assessment method

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Nalfurafine Hydrochloride 5μgExperimental Treatment1 Intervention
Oral administration after dinner, once daily for 14 consecutive days
Group II: Nalfurafine Hydrochloride 2.5μgExperimental Treatment1 Intervention
Oral administration after dinner, once daily for 14 consecutive days
Group III: PlaceboPlacebo Group1 Intervention
Oral administration after dinner, once daily for 14 consecutive days

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Who is running the clinical trial?

Shenyang Sunshine Pharmaceutical Co., LTD.Lead Sponsor
18 Previous Clinical Trials
1,991 Total Patients Enrolled
~28 spots leftby Jul 2025
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