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Double-blind, 3 Parallel Randomized Groups, Therapeutic Confirmatory. Clinical Trial to Compare the Efficacy of Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects in an EEC.
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.
Details
| Lead sponsor | UCB Pharma |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 403 |
| Start date | 2006-07 |
| Completion | 2006-10 |
Conditions
- Rhinitis, Allergic, Seasonal
Interventions
- Levocetirizine
Primary outcomes
- Compare efficacy of Levocetirizine 5 mg to montelukast 10 mg as measured by the mean change from baseline of major symptoms related to SAR in ragweed sensitive subjects.
Countries
Canada