Phase 3
Completed N=62
Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
prurigo nodularis · Nodularis Prurigo · Prurigo · Pruritus
Source: ClinicalTrials.gov NCT02174419 ↗
Enrolled (actual)
62
Serious AEs
3.2%
Results posted
Aug 2020
Primary outcomePrimary: Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale — 27.3; 44.4; 36.4 percentage of subjects
◆ Published Evidence
Established
49citations · ~12 / year
Efficacy and safety of oral nalbuphine extended release in prurigo nodularis: results of a phase 2 randomized controlled trial with an open-label extension phase.
Summary
The primary objectives of the study are 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 patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.
Linked Publications (3)
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Efficacy and safety of oral nalbuphine extended release in prurigo nodularis: results of a phase 2 randomized controlled trial with an open-label extension phase.
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Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation.
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A population pharmacokinetic-pharmacodynamic model evaluating efficacy of nalbuphine extended-release in patients with prurigo nodularis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale |
27.3; 44.4; 36.4 | — |
| SECONDARY Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subject suffering from generalized prurigo nodularis
- Have demonstrated pruritus intensity during screening
- Male or female who are at least 18 years old at the time of consent
Exclusion Criteria
- Subject has chronic pruritus resulting from other conditions
- Subject has a history of substance abuse within the past year
- Subject has a known drug allergy to opioids
- Subject is a pregnant or lactating female
Data sourced from ClinicalTrials.gov (NCT02174419) and the linked publication. 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.