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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
Placebo tablets BID administered for 10 weeks
Case Western Reserve University
Cleveland, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Münster
Münster, Germany
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale
The number of subjects who reported at least a 30% reduction from baseline to Week 10, expressed as a percentage of subjects in the particular arm/group who were evaluated,
Time frame: Baseline, Week 10
Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale
Time frame: Baseline, Week 10
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