drugset / Trial / NCT00536380

Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849)

NCT00536380 ↗

Phase 4 Completed 314 enrolled Organon and Co
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20 mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria. Subjects with chronic urticaria who are currently taking a second generation antihistamine will be treated with desloratadine (5, 10, or 20 mg) for 28 days.

Timeline

Start
2007-09
Primary completion
2009-04
Completion
2009-04

Outcome

Missed primary endpoint

registry analysis (unspecified test); 5-mg Desloratadine vs 20-mg Desloratadine; p = 0.721; ANCOVA NCT00536380 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Desloratadine Small molecule 5 mg —
Subject Desloratadine Small molecule 10 mg —
Subject Desloratadine Small molecule 20 mg —