A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
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
1 other identifier
interventional
580
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2008
Shorter than P25 for phase_4
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
November 17, 2009
CompletedAugust 31, 2011
December 1, 2009
3 months
April 1, 2008
July 28, 2009
August 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)
Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). Total score ranges from 0 to 15.
Over the total treatment period (14 days)
Secondary Outcomes (89)
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period
Baseline and at endpoint of the 2 week treatment period
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1
Baseline and week 1
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2
Baseline and week 2
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period
Baseline and at endpoint of the 2 week treatment period
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1
Baseline and week 1
- +84 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORMatched placebo tablets
LCTZ
EXPERIMENTAL5 mg tablet
Interventions
Eligibility Criteria
You may qualify if:
- 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
- % compliance on run in study medication and 80% compliance on completing the diary
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (38)
Unknown Facility
Tucson, Arizona, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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San Jose, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Gainesville, Georgia, United States
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Lawrenceville, Georgia, United States
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Stockbridge, Georgia, United States
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Normal, Illinois, United States
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Louisville, Kentucky, United States
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Harvard, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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Novi, Michigan, United States
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Minneapolis, Minnesota, United States
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Berlin, New Jersey, United States
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Skillman, New Jersey, United States
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Verona, New Jersey, United States
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Rochester, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Lincoln, Rhode Island, United States
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Germantown, Tennessee, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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South Burlington, Vermont, United States
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Arlington, Virginia, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB Pharma
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2008
First Posted
April 4, 2008
Study Start
April 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
August 31, 2011
Results First Posted
November 17, 2009
Record last verified: 2009-12