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| ID | Type | Description | Link |
|---|---|---|---|
| RPCE08K2403 | |||
| 2007-003458-28 | EudraCT Number |
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To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Levocetirizine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levocetirizine 1.25 mg | Drug | Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) | Baseline, 14 days | |
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval | The RR interval refers to the respective time interval in the Electrocardiogram (ECG) | Baseline, 14 days |
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval | The PR interval refers to the respective time interval in the Electrocardiogram (ECG) | Baseline, 14 days |
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration | The QRS duration refers to the respective time interval in the Electrocardiogram (ECG) | Baseline, 14 days |
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval | The QT interval refers to the respective time in the Electrocardiogram (ECG) | Baseline, 14 days |
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) | The QT interval refers to the respective time interval in the Electrocardiogram (ECG) | Baseline, 14 days |
| Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin | Baseline, 14 days | |
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT) | Baseline, 14 days |
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Inclusion Criteria:
Exclusion Criteria:
Any clinically significant medical condition or abnormality other than the primary diagnosis for which an antihistamine is indicated
Be initiating or changing the dose of an immunotherapy regimen during the course of the study (Visit 1 to Visit 4)
Any Electrocardiogram (ECG) parameters, including a QTcF interval > 443 msec measured by an ECG obtained at the Screening Visit, outside the normal reference ranges
Any clinical laboratory tests performed at Screening Visit, other than those related with the allergic condition, outside the reference ranges. Subjects having values outside the accepted reference range can be included if in the Investigator's opinion, they are of no clinical significance
Personal history of seizure, febrile seizure or sleep apnea
Below the lower 5th or above 95th percentile for body weight and/or height based upon CDC Growth Charts for Body Weight and Length
Allergy or intolerance to levocetirizine dihydrochloride or its excipients, or to any other piperazine derivatives, such as hydroxyzine, cetirizine, cyclizine, meclozine, buclizine
Current or past intake (including exposure through breast milk) of the following medications within the specified wash-out period before the Randomization Visit (V2):
Previous participation in another clinical/pharmacological trial within the past month prior to V1
Have already participated in this study or participated in this study at another site
Children of any member of the study site staff
Sibling with sleep apnea or sudden infant death syndrome (SIDS)
Exposure to other conditions known to be potential risk factors for SIDS, such as but not limited to (this should be determined on a case by case basis taking into account the subject's entire medical history and environmental living conditions):
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20819318 | Derived | Hampel F, Ratner P, Haeusler JM. Safety and tolerability of levocetirizine dihydrochloride in infants and children with allergic rhinitis or chronic urticaria. Allergy Asthma Proc. 2010 Jul-Aug;31(4):290-5. doi: 10.2500/aap.2010.31.3349. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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One subject was randomized to levocetirizine but received placebo; hence the number of subjects in both treatment groups in the Safety Population differs by 1 from the number of the subjects randomized (STARTED) to the respective treatment group. All results are presented for the safety population for which the subjects were analyzed as treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). |
| FG001 | Levocetirizine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Other | Placebo oral liquid once a day for two weeks |
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The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
| 7 days |
| Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) | The QT interval refers to the respective time interval in the Electrocardiogram (ECG) | 14 days |
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST) | Baseline, 14 days |
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen | Baseline, 14 days |
| Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine | Baseline, 14 days |
| Hot Springs |
| Arkansas |
| United States |
| Jonesboro | Arkansas | United States |
| Little Rock | Arkansas | United States |
| Bakersfield | California | United States |
| Crescent City | California | United States |
| Huntington Beach | California | United States |
| Los Angeles | California | United States |
| Orange | California | United States |
| Roseville | California | United States |
| Stockton | California | United States |
| Albany | Georgia | United States |
| Gainesville | Georgia | United States |
| Normal | Illinois | United States |
| Bridgeton | Missouri | United States |
| Omaha | Nebraska | United States |
| Oklahoma City | Oklahoma | United States |
| Barnwell | South Carolina | United States |
| Spartanburg | South Carolina | United States |
| Kingsport | Tennessee | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| El Paso | Texas | United States |
| San Antonio | Texas | United States |
| Sugarland | Texas | United States |
| Richmond | Virginia | United States |
Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). |
| BG001 | Levocetirizine | Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | months |
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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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) | Safety Population; only non-missing values were analyzed | Posted | Mean | Standard Deviation | beats per minute | Baseline, 14 days |
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| Primary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval | The RR interval refers to the respective time interval in the Electrocardiogram (ECG) | Safety Population; only non-missing values were analyzed | Posted | Mean | Standard Deviation | milliseconds | Baseline, 14 days |
|
| |||||||||||||||||||||||||||||
| Primary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval | The PR interval refers to the respective time interval in the Electrocardiogram (ECG) | Safety Population; only non-missing values were analyzed | Posted | Mean | Standard Deviation | milliseconds | Baseline, 14 days |
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| Primary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration | The QRS duration refers to the respective time interval in the Electrocardiogram (ECG) | Safety Population; only non-missing values were analyzed | Posted | Mean | Standard Deviation | milliseconds | Baseline, 14 days |
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| Primary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval | The QT interval refers to the respective time in the Electrocardiogram (ECG) | Safety Population; only non-missing values were analyzed | Posted | Mean | Standard Deviation | milliseconds | Baseline, 14 days |
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| Primary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) | The QT interval refers to the respective time interval in the Electrocardiogram (ECG) | Safety Population; only non-missing values were analyzed | Posted | Mean | Standard Deviation | milliseconds | Baseline, 14 days |
|
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| Primary | Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) | The QT interval refers to the respective time interval in the Electrocardiogram (ECG) | Safety Population; only non-missing values were analyzed | Posted | Mean | Standard Deviation | milliseconds | 7 days |
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| Primary | Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) | The QT interval refers to the respective time interval in the Electrocardiogram (ECG) | Safety Population; only non-missing values were analyzed | Posted | Mean | Standard Deviation | milliseconds | 14 days |
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| Secondary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin | Safety Population; only non-missing values were analyzed | Posted | Median | Full Range | micromole per liter [µmol/L] | Baseline, 14 days |
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| Secondary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT) | Safety Population; only non-missing values were analyzed | Posted | Median | Full Range | unit per liter [U/L] | Baseline, 14 days |
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| Secondary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST) | Safety Population; only non-missing values were analyzed | Posted | Median | Full Range | unit per liter [U/L] | Baseline, 14 days |
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| Secondary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen | Safety Population; only non-missing values were analyzed | Posted | Median | Full Range | millimole per liter [mmol/L] | Baseline, 14 days |
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| Secondary | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine | Safety Population; only non-missing values were analyzed | Posted | Median | Full Range | micromole per liter [μmol/L] | Baseline, 14 days |
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Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2).
Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
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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 | Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). | 0 | 24 | 17 | 24 | ||
| EG001 | Levocetirizine | Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). | 1 | 45 | 29 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis media acute | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus arrhythmia | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Ear pruritus | Ear and labyrinth disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Teething | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Thirst | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Bronchitis acute | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Increased appetite | Metabolism and nutrition 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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| Insomnia | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue 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 | +1 877 822 9493 |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D000080223 | Chronic Urticaria |
| D006967 | Hypersensitivity |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C472067 | levocetirizine |
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| >=65 years |
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| Male |
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