drugset / Trial / NCT00421109

Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

NCT00421109 ↗

Phase 3 Completed 522 enrolled Faes Farma, S.A.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.

Timeline

Start
2006-07
Primary completion
2007-07
Completion
2007-07

Outcome

Met primary endpoint

paper Bilastine reduced patients' mean reflective and instantaneous TSS from baseline to a significantly greater degree than placebo (P < 0.001); PMID 19860762 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bilastine Small molecule 20 mg —
Comparator Levocetirizine Unknown 5 mg —