Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

Phase

2/3

Condition

Warts

Eczema (Atopic Dermatitis)

Atopic Dermatitis

Treatment

nalbuphine HCl ER tablets 180 mg BID

Placebo tablets BID

nalbuphine HCl ER tablets 90 mg BID

Clinical Study ID

NCT02174419

TR03

2013-005627-17

Ages 18-75
All Genders

Study 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

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

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

Study Design

nalbuphine HCl ER tablets 180 mg BID

2/3

March 01, 2015

August 31, 2016

Connect with a study center

University of Münster
Münster,
Germany
Site Not Available
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, Dolnoslaskie 50-368
Poland
Site Not Available
Case Western Reserve University
Cleveland, Ohio 44106
United States
Site Not Available
Temple University Hospital
Philadelphia, Pennsylvania 19140
United States
Site Not Available

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