NCT00346606

The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Lotus Pharmaceutical · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Idiopathic Urticaria
• Urticaria

Interventions

Type	Name	Description
DRUG	Denosin® and Xyzal®

Timeline

• Start date: 2006-01-01
• First posted: 2006-06-30
• Last updated: 2006-06-30

Locations

1 site across 1 country: Taiwan