At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 132 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 Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age
In Brief
A Phase 2 clinical trial evaluating Olopatadine Hydrochloride Nasal Spray 0.6% and Olopatadine Hydrochloride Nasal Spray Vehicle for Allergic Rhinitis. Completed, enrolled 132 participants across 1 site.
Detailed Summary
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedNov 2008
Primary CompletionDec 2008
TodayJul 2026
First PostedNov 19, 2008
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.6 years ago
Interventions
Olopatadine Hydrochloride Nasal Spray 0.6%drug
one spray in each nostril twice daily for 2 weeks
Olopatadine Hydrochloride Nasal Spray Vehicledrug
one spray in each nostril twice daily for 2 weeks