Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects
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...
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.”
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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- 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 Investigator Information
Lead Investigator: UCB, Inc. Industry
Overall Clinical Trial Officials and Contacts
UCB Clinical Trial Call Center Study Director UCB, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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 content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00295022
