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...
Date First Received: February 20, 2006
Last Updated: March 6, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 4 | Start Date: August 2006
Overall Status: Completed
Estimated Enrollment: 403
Brief Summary
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.”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Study Primary Completion Date: October 2006
Intervention(s) in this Clinical Trial
- Drug: Levocetirizine
Outcome Measures for this Clinical Trial
Primary 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 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
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- Subjects who obtain a minimum sum score, considering SAR related symptoms (mean value), as defined by the protocol
Exclusion Criteria:
- Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
- Have used forbidden concomitant medications as defined by the protocol
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 19 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
Marie-Etienne Pinelli, MD Study Director UCB
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00295022
Study ID Number: A00414
ClinicalTrials.gov Identifier: NCT00295022
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
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