At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,388 enrolled
Drug / intervention
Olopatadine Hydrochloride Nasal Spray 0.6% +1 moredrug
Likely dose
Not stated in 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.
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
In Brief
A Phase 3 clinical trial evaluating Olopatadine Hydrochloride Nasal Spray 0.6% and Vehicle for Seasonal Allergic Rhinitis. Completed, enrolled 2,388 participants across 1 site.
Detailed Summary
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedDec 2007
Primary CompletionNov 2008
TodayJul 2026
First PostedDec 21, 2007
Enrollment StartSep 1, 2007
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.5 years ago
Interventions
Olopatadine Hydrochloride Nasal Spray 0.6%drug
Olopatadine HCl 1 or 2 sprays per nostril twice daily
Vehicledrug
Vehicle 1 or 2 sprays per nostril twice daily