Open AccessAprepitant in Anti-histamine-refractory Chronic Nodular Prurigo: A Multicentre, Randomized, Double-blind, Placebo-controlled, Cross-over, Phase-II trial (APREPRU)
Author(s) -
Athanasios Tsianakas,
Claudia Zeidler,
Claudia Riepe,
Matthias Borowski,
Caroline Forner,
Joachim Gerß,
Martin Metz,
Petra Staubach,
Ulrike Raap,
Martin Kaatz,
Marc Urban,
Thomas A. Luger,
Sonja Ständer
Publication year - 2019
Publication title -
acta dermato-venereologica
Language(s) - Uncategorized
Resource type - Journals
SCImago Journal Rank - 0.982
H-Index - 83
eISSN - 1651-2057
pISSN - 0001-5555
DOI - 10.2340/00015555-3120
Subject(s) - aprepitant , medicine , placebo , crossover study , visual analogue scale , histamine , refractory (planetary science) , antipruritic , randomized controlled trial , clinical trial , prurigo , anesthesia , gastroenterology , dermatology , nausea , antiemetic , pathology , physics , alternative medicine , astrobiology
The aim of this multicentre, randomized, double-blind, placebo-controlled, cross-over, phase-II study was to determine the antipruritic effect of aprepitant vs. placebo in 58 patients with anti-histamine-refractory chronic pruritus in chronic nodular prurigo. Patients were randomized to receive either first oral aprepitant 80 mg/day or placebo for 4 weeks. Following a 2-week wash-out phase, the patients were crossed-over to receive the other treatment for 4 weeks. Primary efficacy criterion was the intra-individual difference between mean itch intensity (visual analogue scale) at baseline compared with the end of treatment period. Prurigo lesions, pruritus course, quality of life, patient benefits, and safety were secondary parameters. No significant differences were found between aprepitant treatment and placebo for any of the parameters investigated. Under the experimental conditions of the study, aprepitant, 80 mg daily for 4 weeks, did not have an antipruritic effect in patients with chronic prurigo. (DRKS00005594; EudraCT Number: 2013-001601-85).