At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 332 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 With or Without the Presence of Nasal Polyps
In Brief
A Phase 3 clinical trial evaluating OPN-375 for Chronic Rhinosinusitis. Completed, enrolled 332 participants across 92 sites in 8 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 (CS) with or without nasal polyps.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Rhinosinusitis
CountriesBulgaria, Canada, Georgia, Poland, Russia, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartNov 2018
First PostedDec 2018
Primary CompletionJan 2022
TodayJul 2026
First PostedDec 20, 2018
Enrollment StartNov 27, 2018
Primary CompletionJan 19, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.5 years ago
Interventions
OPN-375drug
OPN-375, BID