Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.~Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.~Primary endpoint: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries during the first two weeks of the treatment.~Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.~Primary endpoint:~To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the patient diaries during the first two weeks of treatment~Secondary Endpoints- To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries over the 6 weeks.~To evaluate the reflective average AM/PM scores for number of hives, size of largest hive, and total symptom score (sum of pruritus, number of hives, and size of largest hive scores).~Average individual AM/PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.~AM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.~PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.~PM reflective scores for pruritus, number of hives, and size of largest hive are also evaluated.~The interference with sleep (AM reflective), and interference with daily activities (PM reflective) are other secondary efficacy outcomes.~Therapeutic response will be evaluated at visit 3~5.~Safety will be evaluated including vital signs are recorded at all visits, whereas sleep latency using Epworth Sleepiness Scale (ESS) questionnaire and Visual analogue Scale (VAS) are scored at visit 2~5. Stanford Sleepiness Scale (SSS) are scored according to the instructions of diary cards at all visits. All adverse events are recorded and graded for severity at visit 2~5.
Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.~Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.~Primary end point: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries during the first two weeks of the treatment.~Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.