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A Study of the Efficacy, Safety, and Quality of Life (QOL) in Patients With Chronic Idiopathic Urticaria Dosed With AERIUS Tablets (Desloratadine 5 mg, 10 mg, or 20 mg Once Daily)
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.
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 314 |
| Start date | 2007-09 |
| Completion | 2009-04 |
Conditions
- Chronic Idiopathic Urticaria
Interventions
- 5-mg Desloratadine
- 10-mg Desloratadine
- 20-mg Desloratadine
Primary outcomes
- Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg — Baseline and 4 treatment weeks
The UAS is a composite diary-recorded score. The diary recorded scores included wheal score and pruritus score with numeric severity intensity ratings of 0 = none to 3 = intense. The scoring was to be done twice daily within one hour of arising and in the evening, approximately 12 hours later. Scoring was "reflective", covering the 12-hour period since the previous recording. The daily UAS is the average of the morning and evening scores. The final week by definition was the terminal week. It was the last week participants stayed for the treatment period.