Clinical trial NCT00619801: Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
Official title: A Multi-Center, Randomized, Double Blind, Placebo Controlled Parallel Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation b.i.d Dosing in Children Aged 1 to < 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Chronic Urticaria
Keywords: Xyzal
Levocetirizine
Allergy
Children
Seasonal Allergies
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 173
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis or chronic urticaria of unknown origin.


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

Primary outcomes:
measure: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
timeFrame: Baseline, 14 days
measure: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
timeFrame: Baseline, 14 days
measure: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval
timeFrame: Baseline, 14 days
measure: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
timeFrame: Baseline, 14 days
measure: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval
timeFrame: Baseline, 14 days
measure: 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)
timeFrame: Baseline, 14 days
measure: Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)
timeFrame: 7 days
measure: 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)
timeFrame: 14 days
Secondary outcomes:
measure: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
timeFrame: Baseline, 14 days
measure: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
timeFrame: Baseline, 14 days
measure: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)
timeFrame: Baseline, 14 days
measure: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
timeFrame: Baseline, 14 days
measure: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
timeFrame: Baseline, 14 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
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state: Arkansas
city: Beverly Hills
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state: California
city: Crescent City
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state: California
city: Huntington Beach
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state: California
city: Mission Viejo
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state: California
city: San Diego
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city: Wildomar
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state: California
city: Denver
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state: Colorado
city: Pueblo
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state: Colorado
city: Savannah
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state: Georgia
city: Stockbridge
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state: Georgia
city: Normal
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state: Illinois
city: Overlook Park
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state: Kansas
city: Owensboro
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state: Kentucky
city: Metarie
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state: Louisiana
city: Baltimore
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state: Maryland
city: Omaha
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state: Nebraska
city: Papillon
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state: Nebraska
city: Oklahoma City
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state: Oklahoma
city: Medford
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state: Oregon
city: Portland
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state: Oregon
city: Barnwell
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state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: New Braunfels
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.