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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00619801 |
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.
Condition | Intervention | Phase |
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Allergic Rhinitis Chronic Urticaria |
Drug: Levocetirizine Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study |
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 |
Enrollment: | 173 |
Study Start Date: | March 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator |
Drug: Placebo
Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
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Levocetirizine: Experimental |
Drug: Levocetirizine
Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
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Ages Eligible for Study: | 2 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | 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)
Exclusion Criteria:
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | A00426, RPCE07K2404 |
Study First Received: | February 11, 2008 |
Results First Received: | July 28, 2009 |
Last Updated: | July 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00619801 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Xyzal Levocetirizine Allergy Children Seasonal Allergies |
Neurotransmitter Agents Otorhinolaryngologic Diseases Skin Diseases Rhinitis Urticaria Anti-Allergic Agents Cetirizine Histamine Hypersensitivity |
Histamine Antagonists Respiratory Tract Diseases Respiratory Tract Infections Levocetirizine Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine phosphate Histamine H1 Antagonists |
Neurotransmitter Agents Skin Diseases, Vascular Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Skin Diseases Immune System Diseases Physiological Effects of Drugs Histamine Agents Rhinitis Urticaria Anti-Allergic Agents Cetirizine |
Pharmacologic Actions Nose Diseases Hypersensitivity Histamine Antagonists Respiratory Tract Diseases Respiratory Tract Infections Levocetirizine Therapeutic Uses Hypersensitivity, Immediate Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating |