Trial Information

Summary: Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months (BALL)

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.

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.
• Previous participation in another clinical/pharmacological trial within the past month prior to V1.
• Sibling with sleep apnea or sudden infant death syndrome (SIDS).
• Exposure to other conditions known to be potential risk factors for SIDS.

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Trial listings updated: June 1, 2008 at 6:43:58 AM