At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 223 enrolled
Drug / intervention
OPN-375drug
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.
A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps
In Brief
A Phase 3 clinical trial evaluating OPN-375 for Chronic Rhinosinusitis. Completed, enrolled 223 participants across 87 sites in 10 countries.
Detailed Summary
This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic Rhinosinusitis (CRS) without nasal polyps
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Rhinosinusitis
CountriesAustralia, Bulgaria, Czechia, Georgia, New Zealand, Poland, Romania, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartJun 2019
Primary CompletionMay 2022
TodayJul 2026
First PostedMay 23, 2019
Enrollment StartJun 6, 2019
Primary CompletionMay 4, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.1 years ago
Interventions
OPN-375drug
OPN-375, BID