drugset / Trial / NCT00375713

Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema

NCT00375713

Phase 3 Completed 466 enrolled UCB Pharma
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms

Timeline

Start
2005-10
Primary completion
2006-05
Completion
2006-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cetirizine Other / unclassified 10 mg
Subject Levocetirizine Unknown 5 mg
Background Hydrocortisone Other / unclassified 1 % Topical

Indications