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”

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.

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine
  • Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
• Drug: Placebo
  • Placebo oral drops (5 drops) dosed twice a day for 2 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
• Experimental: Levocetirizine

Primary Measures

• Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
  • Time Frame: Baseline, 14 days
    Safety Issue?: No
• Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
  • Time Frame: Baseline, 14 days
    Safety Issue?: No
• Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval
  • Time Frame: Baseline, 14 days
    Safety Issue?: No
• Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
  • Time Frame: Baseline, 14 days
    Safety Issue?: No
• Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval
  • Time Frame: Baseline, 14 days
    Safety Issue?: No
• 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)
  • Time Frame: Baseline, 14 days
    Safety Issue?: No
• Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)
  • Time Frame: 7 days
    Safety Issue?: No
• 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)
  • Time Frame: 14 days
    Safety Issue?: No

Secondary Measures

• Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
  • Time Frame: Baseline, 14 days
    Safety Issue?: No
• Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
  • Time Frame: Baseline, 14 days
    Safety Issue?: No
• Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)
  • Time Frame: Baseline, 14 days
    Safety Issue?: No
• Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
  • Time Frame: Baseline, 14 days
    Safety Issue?: No
• Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
  • Time Frame: Baseline, 14 days
    Safety Issue?: No

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 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.
• Caregivers(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 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):
• 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 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 6 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00619801

Study ID Number: A00426

ClinicalTrials.gov Identifier: NCT00619801

Health Authority: United States: Food and Drug Administration

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