Urticaria Clinical Trial
Official title:
A Randomized, Double-Blind, Active-Controlled, Parallel-Group Study to Compare the Efficacy and Safety of Desloratadine 5mg (Denosin®) With Levocetirizine 5mg (Xyzal®) in the Treatment of Chronic Idiopathic Urticaria Patients
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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