Official Title: “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Impact on Health-Related Quality of Life of Levocetirizine 5 mg Once Daily Given for 2 Weeks in Subjects 18 yr of Age and Older With Seasonal Allergic Rhinitis”

The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: levocetirizine dihydrochloride
  • 5 mg tablet, P.O. , once daily
• Drug: placebo
  • matching placebo tablet, taken orally, once daily

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Matched placebo tablets
• Experimental: 2
  • 5 mg tablet

Primary Measures

• The primary objective is to compare the efficacy of levocetirizine and placebo as measured by total symptom score
  • Time Frame: over the total treatment period
    

Secondary Measures

• The key secondary objective is to compare the effects of levocetirizine and placebo on rhinitis-related QoL
  • Time Frame: at endpoint, defined as the last available post-baseline observation
    

Inclusion Criteria:

• Subjects with a history of SAR symptoms
• A positive skin prick test at least one grass allergen
• Moderate - severe SAR symptoms at baseline
• Women of childbearing potential must use a medically acceptable form of contraception
• 80% compliance on run in study medication and 80% compliance on completing the diary

Exclusion Criteria:

• The presence of any clinically significant comorbid disease which may interfere with the study assessments
• The presence of renal disease
• Pregnant or breastfeeding
• Subject is currently participating in another clinical trial
• Known hypersensitivity to piperazines or any of the excipients
• Intake of medications prohibited before the start of the trial
• Subjects who started or changed the dose of immunotherapy
• Rhinitis medicamentosa
• Subjects with a recent history (within the last 2 years) of drug or alcohol abuse

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653224

Study ID Number: A00431

ClinicalTrials.gov Identifier: NCT00653224

Health Authority: United States: Food and Drug Administration