Phase 3
N=373
Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Uremic Pruritus · Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT02143648 ↗Enrolled (actual)
373
Serious AEs
11.7%
Results posted
Sep 2020
Primary outcome: Primary: Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale — -3.10; -3.49; -2.80 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- nalbuphine HCl ER tablets 60 mg BID (Drug); nalbuphine HCl ER tablets 120mg BID (Drug); Placebo tablets BID (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trevi Therapeutics
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale |
-3.10; -3.49; -2.80 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject has been receiving in-center hemodialysis for ≥ 3 months and are currently on a schedule of 3 times a week.
- Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening
- Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening
- Have demonstrated pruritus intensity on the Itch NRS during screening
- Male or female who are at least 18 years old at the time of Screening
Exclusion Criteria
- Subject had a significant alteration in dialysis regimen during the Screening Period
- Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
- Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease
- Has had a history of substance abuse within 6 months prior to completing Screening
- Subject has a known drug allergy to opioids
- Subject is a pregnant or lactating female.
Data sourced from ClinicalTrials.gov (NCT02143648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.