Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months
Condition: Allergic Rhinitis; Chronic Urticaria
MeSH terms: Rhinitis; Rhinitis, Allergic; Urticaria; Chronic Urticaria
Intervention: Levocetirizine 1.25 mg; Placebo
Intervention description: Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks; Placebo oral liquid once a day for two weeks
Intervention MeSH terms: Levocetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 6 Months
Maximum age: 11 Months
Healthy volunteers: No
Keywords: Xyzal; Levocetirizine; Allergy; Children; Seasonal Allergies

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)