At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 69 enrolled
Drug / intervention
Levocetirizine 1.25 mg +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 in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria.
In Brief
A Phase 3 clinical trial evaluating Levocetirizine 1.25 mg and Placebo for Allergic Rhinitis and Chronic Urticaria. Completed, enrolled 69 participants across 26 sites.
Detailed Summary
To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis, Chronic Urticaria
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedMar 2008
Primary CompletionSep 2008
TodayJul 2026
First PostedMar 4, 2008
Enrollment StartMar 1, 2008
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.3 years ago
Interventions
Levocetirizine 1.25 mgdrug
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks
Placeboother
Placebo oral liquid once a day for two weeks