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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
• Experimental: 2

Primary Measures

• To evaluate the safety of levocetirizine in pediatric subjects aged from 1 to less than 6 years.
  • Time Frame: 2 weeks
    Safety Issue?: Yes

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.
• Subjects 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.

Exclusion Criteria:

• Subject must be excluded if they meet any of the following criteria. These criteria must be checked at Screening Visit (V1) and at the Randomization Visit (V2):
• 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.
• 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 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.
• These treatments are also prohibited during the whole trial period i.e., from Screening Visit until End of Treatment Visit. In case a wash-out period is needed, the caregivers should sign the informed consent before stopping any treatment.
• 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: 1 Year

Maximum Age for this Clinical Trial: 5 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on September 05, 2008

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