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Opioid Analgesic

nalbuphine HCl ER 60mg for Uremic Pruritus

Phase 2 & 3
Waitlist Available
Research Sponsored by Trevi Therapeutics
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 8 weeks
Awards & highlights

Summary

The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.

Eligible Conditions
  • Uremic Pruritus
  • Itching

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: nalbuphine HCl ER 60mgExperimental Treatment1 Intervention
nalbuphine HCl ER tablets 60 mg BID
Group II: nalbuphine HCl ER 120mgExperimental Treatment1 Intervention
nalbuphine HCl ER tablets 120 mg BID
Group III: Sugar pillPlacebo Group1 Intervention
Placebo tablets BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nalbuphine
FDA approved
Nalbuphine
FDA approved

Find a Location

Who is running the clinical trial?

Trevi TherapeuticsLead Sponsor
10 Previous Clinical Trials
1,014 Total Patients Enrolled
2 Trials studying Uremic Pruritus
189 Patients Enrolled for Uremic Pruritus
Thomas Sciascia, MDStudy DirectorTrevi Therapeutics
3 Previous Clinical Trials
259 Total Patients Enrolled
1 Trials studying Uremic Pruritus
167 Patients Enrolled for Uremic Pruritus
~33 spots leftby Oct 2025
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