A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
NCT ID: NCT00621959
Last Updated: 2020-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
596 participants
INTERVENTIONAL
2008-03-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matched placebo tablets once daily
placebo
0mg (matching oral tablet)for 14 days
LCTZ
5 mg levocetirizine dihydrochloride tablet
levocetirizine dihydrochloride
5mg daily (oral tablet) for 14 days
Interventions
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levocetirizine dihydrochloride
5mg daily (oral tablet) for 14 days
placebo
0mg (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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Scottsdale, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Huntington Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Albany, Georgia, United States
Lilburn, Georgia, United States
Savannah, Georgia, United States
Owensboro, Kentucky, United States
Metairie, Louisiana, United States
Winston-Salem, North Carolina, United States
Tulsa, Oklahoma, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Katy, Texas, United States
New Braunfels, Texas, United States
Plano, Texas, United States
San Angelo, Texas, United States
San Antonio, Texas, United States
Waco, Texas, United States
Countries
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References
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Segall N, Gawchik S, Georges G, Haeusler JM. Efficacy and safety of levocetirizine in improving symptoms and health-related quality of life in US adults with seasonal allergic rhinitis: a randomized, placebo-controlled study. Ann Allergy Asthma Immunol. 2010 Mar;104(3):259-67. doi: 10.1016/j.anai.2009.12.003.
Mansfield LE, Hampel F, Haeusler JM, Georges G. Study of levocetirizine in seasonal allergic rhinitis. Curr Med Res Opin. 2010 Jun;26(6):1269-75. doi: 10.1185/03007991003745233.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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A00430
Identifier Type: -
Identifier Source: org_study_id
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