Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects
This study has been completed.
Information provided by:
First received: February 20, 2006
Last updated: December 13, 2013
Last verified: September 2009
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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 EEU.|
Resource links provided by NLM:
Drug Information available for: Levocetirizine Levocetirizine dihydrochloride Montelukast sodium MontelukastU.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Compare the efficacy of Levocetirizine to montelukast as measured by the mean change from baseline of major symptoms (mean value) related to Seasonal Allergic Rhinitis.
Secondary Outcome Measures:
- Efficacy of each active arm in reducing other SAR symptoms (calculated as mean value reduction for grouped symptoms and as absolute value reduction for each individual symptom), at different time points; Safety
|Study Start Date:||August 2006|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
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