Safety Study of Levocetirizine Dihydrochloride Oral Liqui... | NCT00619801

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Levocetirizine	Experimental		Drug: Levocetirizine

Name	Type	Description	Arm Group Labels	Other Names
Levocetirizine	Drug	Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks	Levocetirizine

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 duration 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 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 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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatient, male or female pediatric subject, ages 1 to less than 6 years old at the Randomization Visit (V2) (1 - < 6 years old)
The subject must present at least one of the following symptoms, most commonly associated with allergic rhinitis or chronic urticaria: nasal itching, sneezing, rhinorrhea, nasal congestion, tearing, eye redness and itching of eyes, ears and/or palate, skin wheals and itching of the skin
Subjects (age 2 to less than 6 years only) suffering from allergic rhinitis (AR) should have a documented allergy measured by positive skin prick test or RAST (Radioallergosorbent Test) performed within the last 6 months prior to randomization
Candidate for antihistamine treatment or received antihistamine in the past for similar symptoms as those presenting
Caregiver(s) have been informed of the nature and aims of the study and have given their written informed consent for the subject to participate in this study
Caregiver(s) able to understand information given, the text of the informed consent, and be able to complete the daily record card (DRC)

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 the 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 of the following medications (including exposure through breast milk) within the specified wash-out period before the Randomization Visit (V2):
1. Systemic corticosteroids within the past 28 days
2. Leukotriene-receptor antagonists (e.g. montelukast [Singulair] or zafirlukast [Accolate] within the past 7 days)
3. Mast-cell stabilizers (e.g. cromolyn or nedocromil) within the past 7 days
4. Other antihistamines or cough and cold preparations (with the exception of single ingredient guaifenesin products) or over-the-counter (OTC) sleep aid medications within the past 7 days
5. Systemic antibiotics within the past 7 days
6. Other concomitant medications that will interfere with the study, in the opinion of the investigator
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

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

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

ID	Title	Description
FG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
FG001	Levocetirizine

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

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants	OG00056 OG001110

Title

Denominators

Categories

Title	Measurements
	OG000-1.5± 14.1 OG0011.3± 14.2

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

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants

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

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants

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 duration in the Electrocardiogram (ECG).

Safety Population; only non-missing values were analyzed

Posted

Mean

Standard Deviation

milliseconds

Baseline, 14 days

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants

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 interval in the Electrocardiogram (ECG).

Safety Population; only non-missing values were analyzed

Posted

Mean

Standard Deviation

milliseconds

Baseline, 14 days

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants

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

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants

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

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants

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

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants

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

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants	OG000

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

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants	OG000

Secondary

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)

Safety Population; only non-missing values were analyzed

Posted

Median

Full Range

unit per liter [U/L]

Baseline, 14 days

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants	OG000

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

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants	OG000

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

ID	Title	Description
OG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
OG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Eye swelling	Eye disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0002 events2 affected59 at risk EG0014 events4 affected114 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0002 events2 affected59 at risk EG0014 events4 affected114 at risk
Teething	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected114 at risk
Eructation	Gastrointestinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Constipation	Gastrointestinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Pyrexia	General disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0015 events5 affected114 at risk
Fatigue	General disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected114 at risk
Pain	General disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Hunger	General disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Thirst	General disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0002 events2 affected59 at risk EG0013 events3 affected114 at risk
Nasopharyngitis	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Sinusitis	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0002 events2 affected59 at risk EG0011 events1 affected114 at risk
Otitis media	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0013 events3 affected114 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected114 at risk
Viral rash	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0002 events2 affected59 at risk EG0011 events1 affected114 at risk
Viral pharyngitis	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Gastroenteritis	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0012 events2 affected114 at risk
Folliculitis	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Hordeolum	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Urinary tract infection	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Alanine aminotransferase increased	Investigations	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Somnolence	Nervous system disorders	MedDRA 9.0	Non-systematic Assessment	EG0002 events2 affected59 at risk EG0011 events1 affected114 at risk
Headache	Nervous system disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected114 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 9.0	Non-systematic Assessment	EG0003 events3 affected59 at risk EG0010 events0 affected114 at risk
Sleep disorder	Psychiatric disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0012 events2 affected114 at risk
Nervousness	Psychiatric disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Middle insomnia	Psychiatric disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Restlessness	Psychiatric disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0006 events5 affected59 at risk EG0014 events4 affected114 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected114 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0012 events2 affected114 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0012 events1 affected114 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected114 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected114 at risk

ID	Type	Description	Link
RPCE07K2404
2015-000205-39	EudraCT Number

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

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

ID	Title	Description
BG000	Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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 (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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

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 at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).			0	59	21	59
EG001	Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).			1	114	39	114