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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matched placebo tablets once daily |
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| LCTZ | Experimental | 5 mg levocetirizine dihydrochloride tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levocetirizine dihydrochloride | Drug | 5mg daily (oral tablet) for 14 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) | 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). The total score varies from 0 to 15. | Over the total treatment period (14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20377116 | Derived | 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. | |
| 20350147 | Derived |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matched placebo tablets once daily |
| FG001 | LCTZ | 5 mg levocetirizine dihydrochloride tablet once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| placebo | Drug | 0mg (matching oral tablet)for 14 days |
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| Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days) |
| 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 |
| 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matched placebo tablets once daily |
| BG001 | LCTZ | 5 mg levocetirizine dihydrochloride tablet once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) | 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). The total score varies from 0 to 15. | Number of participants from the Intent-To-Treat (ITT) population with available T5SS over the Total Treatment Period | Posted | Mean | Standard Deviation | points on a scale | Over the total treatment period (14 days) |
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| Secondary | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score | The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6. | Number of participants from the Intent-To-Treat (ITT) population with available overall RQLQ score at Endpoint visit and at Baseline | Posted | Mean | Standard Deviation | points on a scale | Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matched placebo tablets once daily | 2 | 295 | 30 | 295 | ||
| EG001 | LCTZ | 5 mg levocetirizine dihydrochloride tablet once daily | 0 | 301 | 29 | 301 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C472067 | levocetirizine |
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| Male |
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| Superiority or Other (legacy) |
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