Clinical Trial: A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Exploratory Phase IV, Randomised, Double-Blind, Placebo Controlled Crossover Study to Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Experimentally Induced Urticaria Lesi

Brief Summary: The aim of this study is to compare cold urticaria lesions by thermography, volumetry and digital time lapse photography in ACU patients treated with placebo, 5 mg and 20 mg desloratadine. Hypothesis: The updosing of desloratadine (20 mg)is more effective in the treatment of ACU symptoms as compared to standard doses (5 mg desloratadine) and placebo.

Detailed Summary:
Sponsor: Charite University, Berlin, Germany

Current Primary Outcome: Reduction in the development of urticaria lesions (wheal and flare) induced by TempTest challenge as assessed by digital time lapse photography, volumetry and thermography. [ Time Frame: 90 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge. [ Time Frame: 15 minutes ]

Original Secondary Outcome: Same as current

Information By: Charite University, Berlin, Germany

Dates:
Date Received: January 15, 2008
Date Started: November 2006
Date Completion:
Last Updated: January 15, 2008
Last Verified: January 2008