Phase 3
Completed N=36
Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
prurigo nodularis · Nodularis Prurigo · Prurigo
Source: ClinicalTrials.gov NCT02174432 ↗
Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Oct 2020
Primary outcomePrimary: Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) — 34 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 This can indicate results are unpublished — a known publication-bias signal.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 50 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) |
34 | — |
Eligibility Criteria
Inclusion Criteria
- Subject completed participation in the TR03 study
Exclusion Criteria
- Medical condition or other factors that in the opinion of the Investigator may interfere with the conduct of the study.
- Subject is a pregnant or lactating female
Data sourced from ClinicalTrials.gov (NCT02174432). 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.