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Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00315523
First Posted: April 18, 2006
Last Update Posted: December 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UCB Pharma
April 14, 2006
April 18, 2006
December 16, 2013
July 2006
October 2006   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00315523 on ClinicalTrials.gov Archive Site
Reduction in other SAR symptoms at different time points; Safety .
Same as current
Not Provided
Not Provided
 
Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Rhinitis, Allergic, Seasonal
Drug: Levocetirizine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
403
October 2006
October 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00315523
A00415
Not Provided
Not Provided
Not Provided
Not Provided
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center UCB Pharma
UCB Pharma
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP