A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
NCT ID: NCT00653224
Last Updated: 2011-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
580 participants
INTERVENTIONAL
2008-04-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matched placebo tablets
placebo
0 mg daily (matching oral tablet) for 14 days
LCTZ
5 mg tablet
levocetirizine dihydrochloride
5 mg daily (oral tablet) for 14 days
Interventions
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levocetirizine dihydrochloride
5 mg daily (oral tablet) for 14 days
placebo
0 mg daily (matching oral tablet) for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Tucson, Arizona, United States
Los Angeles, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Jose, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Gainesville, Georgia, United States
Lawrenceville, Georgia, United States
Stockbridge, Georgia, United States
Normal, Illinois, United States
Louisville, Kentucky, United States
Harvard, Massachusetts, United States
North Dartmouth, Massachusetts, United States
Novi, Michigan, United States
Minneapolis, Minnesota, United States
Berlin, New Jersey, United States
Skillman, New Jersey, United States
Verona, New Jersey, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Edmond, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Upland, Pennsylvania, United States
Lincoln, Rhode Island, United States
Germantown, Tennessee, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
South Burlington, Vermont, United States
Arlington, Virginia, United States
Milwaukee, Wisconsin, United States
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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A00431
Identifier Type: -
Identifier Source: org_study_id