Conditions: Prurigo Nodularis Nodularis Prurigo Prurigo Pruritus
Keywords: Itch Chronic Itch nalbuphine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 62
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: nalbuphine HCl ER tablets 90 mg BID arm 2: nalbuphine HCl ER tablets 180 mg BID arm 3: Placebo tablets BID

Interventions: intervention 1: nalbuphine HCl ER tablets 90 mg BID intervention 2: nalbuphine HCl ER tablets 180 mg BID intervention 3: Placebo tablets BID
Intervention descriptions: intervention 1: nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks intervention 2: nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks intervention 3: Placebo tablets BID administered for 10 weeks

Protocol document: