Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00628108

Acronym

BALL

Enrollment

Registered

2008-03-04

Start date

2008-03-31

Completion date

2008-09-30

Last updated

2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Chronic Urticaria

Keywords

Xyzal, Levocetirizine, Allergy, Children, Seasonal Allergies

Brief summary

To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.

Interventions

DRUGLevocetirizine 1.25 mg

Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks

OTHERPlacebo

Placebo oral liquid once a day for two weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 11 Months

Healthy volunteers

Inclusion criteria

* Outpatient, male or female pediatric subject, aged from 6 to 11 months (6 months - \< 1 year) at the randomization visit * The subject must present at least one symptom most commonly associated with allergic rhinitis or chronic idiopathic urticaria * Candidate for antihistamine treatment or received antihistamine in the past for similar symptoms as those presenting

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): * Systemic corticosteroids within the past 28 days * Leukotriene-receptor antagonists (e.g. montelukast \[Singulair\] or zafirlukast \[Accolate\] within the past 7 days) * Mast-cell stabilizers (e.g. cromolyn or nedocromil) within the past 7 days * 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 * Systemic antibiotics within the past 7 days * 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 * 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): * Mothers who smoked or abused drugs during pregnancy * Extremely young mothers (defined as age 19 or younger when pregnant) * Children currently exposed to a caregiver which is a heavy cigarette smoker (defined as smoking at least a pack of cigarettes per day) * Babies who sleep regularly on their face or are not put to sleep on their backs * Premature birth gestational age ≤ 37 weeks) or low birth weight (below 10 percentile for gestational age)

Design outcomes

Primary

Measure	Time frame	Description
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)	14 days	The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval	Baseline, 14 days	The PR interval refers to the respective time interval in the Electrocardiogram (ECG)
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration	Baseline, 14 days	The QRS duration refers to the respective time interval in the Electrocardiogram (ECG)
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval	Baseline, 14 days	The QT interval refers to the respective time in the Electrocardiogram (ECG)
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)	Baseline, 14 days	The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)	7 days	The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
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	Baseline, 14 days	The RR interval refers to the respective time interval in the Electrocardiogram (ECG)

Secondary

Measure	Time frame
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)	Baseline, 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
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin	Baseline, 14 days

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
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).	24
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).	45
Total	69

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	3
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Levocetirizine	Placebo	Total
Age, Categorical <=18 years	45 Participants	24 Participants	69 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	8.87 months STANDARD_DEVIATION 1.63	9.03 months STANDARD_DEVIATION 1.8	8.93 months STANDARD_DEVIATION 1.67
Region of Enrollment United States	45 participants	24 participants	69 participants
Sex: Female, Male Female	17 Participants	13 Participants	30 Participants
Sex: Female, Male Male	28 Participants	11 Participants	39 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	17 / 24	29 / 45
serious Total, serious adverse events	0 / 24	1 / 45

Outcome results

Primary