Status:
COMPLETED
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
Lead Sponsor:
UCB Pharma
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00653224
Start Date
April 1 2008
End Date
July 1 2008
Last Update
August 31 2011
Active Locations (38)
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1
Tucson, Arizona, United States
2
Los Angeles, California, United States
3
Sacramento, California, United States
4
San Francisco, California, United States