Back to resultsCompare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Levocetirizine
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Reduction in other SAR symptoms at different time points; Safety .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00315523
Brief Title
Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen
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 EEC.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
403 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levocetirizine
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Reduction in other SAR symptoms at different time points; Safety .
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Mississauga
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18814452
Citation
Patel P, Patel D. Efficacy comparison of levocetirizine vs montelukast in ragweed sensitized patients. Ann Allergy Asthma Immunol. 2008 Sep;101(3):287-94. doi: 10.1016/S1081-1206(10)60494-2.
Results Reference
derived
Learn more about this trial
Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen
We'll reach out to this number within 24 hrs