Clinical trial NCT00628108: Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months
Official title: 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.
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: 2008-03-04
Enrollment: 69
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

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 Aminontransferase (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: Hot Springs
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Crescent City
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Roseville
country: United States
state: California
city: Stockton
country: United States
state: California
city: Albany
country: United States
state: Georgia
city: Gainesville
country: United States
state: Georgia
city: Normal
country: United States
state: Illinois
city: Bridgeton
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Oklahoma City
country: United States
state: Oklahoma
city: Barnwell
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugarland
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.