Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Seasonal
Intervention: Levocetirizine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Marie-Etienne Pinelli, MD, Study Director, Affiliation: UCB
Summary
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: 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: 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
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kingston, Ontario, Canada
Additional Information
Starting date: August 2006
Ending date: October 2006
Last updated: March 6, 2008
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