Phase 3 N=62 Randomized Triple-blind Treatment

Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

Prurigo Nodularis · Nodularis Prurigo · Prurigo · Pruritus

Bottom Line

View on ClinicalTrials.gov: NCT02174419 ↗

Enrolled (actual)

Serious AEs

3.2%

Results posted

Aug 2020

Primary outcome: 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 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: nalbuphine HCl ER tablets 90 mg BID (Drug); nalbuphine HCl ER tablets 180 mg BID (Drug); Placebo tablets BID (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Trevi Therapeutics
Primary completion: Aug 2016

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	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02174419). 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.