Phase 3
N=167
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
Uremic Pruritus · Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT02143973 ↗Enrolled (actual)
167
Serious AEs
32.3%
Results posted
Sep 2020
Primary outcome: Primary: Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) — 133 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- nalbuphine HCl ER (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trevi Therapeutics
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) |
133 | — |
Summary
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.
Eligibility Criteria
Inclusion Criteria
- Subject completed participation in the TR02 study
- Subject is currently receiving in-center hemodialysis at the time of consent
Exclusion Criteria
- Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study
- Subject received opiates on a daily basis during the 1 week prior to screening
- Other than the TR02 Study Drug, Subject received any investigational drug within 4 weeks prior to Screening
- Subject is a pregnant or lactating female
Data sourced from ClinicalTrials.gov (NCT02143973). 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.