Phase 3
Completed N=167
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
Uremic Pruritus · Pruritus
Source: ClinicalTrials.gov NCT02143973 ↗
Enrolled (actual)
167
Serious AEs
32.3%
Results posted
Sep 2020
Primary outcomePrimary: Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) — 133 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) |
133 | — |
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. Informational only — not medical advice.