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 to 11 Months.”

The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 6-11 months who suffer from atopic disease.

Study Type: Interventional

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

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine
  • Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks
• Other: Placebo
  • Placebo oral liquid once a day for two 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 6 months to 11 months.
  • Time Frame: 2 weeks
    Safety Issue?: Yes

• To be eligible to participate in this study, all of the following criteria must be met.
• 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 of the following symptoms, most commonly associated with allergic rhinitis.
• 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.
• 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 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.
• 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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 11 Months

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)  

Overall Contact: UCB Clinical Trial Call Center +1-877-822-9493 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00628108

Study ID Number: A00423

ClinicalTrials.gov Identifier: NCT00628108

Health Authority: United States: Food and Drug Administration