At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 173 enrolled
Drug / intervention
Levocetirizine +1 moredrug
Likely dose
Levocetirizine 1.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Levocetirizine and Placebo for Allergic Rhinitis and Chronic Urticaria. Completed, enrolled 173 participants across 28 sites.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis, Chronic Urticaria
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2008
Enrollment StartMar 2008
Primary CompletionJul 2008
TodayJul 2026
First PostedFeb 21, 2008
Enrollment StartMar 1, 2008
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.4 years ago
Interventions
Levocetirizinedrug
Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
Placebodrug
Placebo oral drops (5 drops) dosed twice a day for 2 weeks.