Phase 3
N=36
Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
Prurigo Nodularis · Nodularis Prurigo · Prurigo
Bottom Line
View on ClinicalTrials.gov: NCT02174432 ↗Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Oct 2020
Primary outcome: Primary: Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) — 34 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
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) |
34 | — |
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.
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.