Efficacy and Safety of OPN-375 186 ug Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps
- Study HIC#:2000023985
- Last Updated:04/21/2023
To evaluate the efficacy of intranasal administration of OPN-375 186 μg twice a day (BID) versus placebo in adolescents with bilateral nasal polyposis and nasal congestion
- Age12 years - 17 years
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- Phone Number: 1-203-737-2168
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Trial Purpose and Description
To evaluate the efficacy of intranasal administration of OPN-375 186 ?g twice a day (BID) versus placebo in adolescents with bilateral nasal polyposis and nasal congestion using the co-primary endpoints:
1) reduction of nasal congestion/obstruction symptoms at the end of Week 4 measured by the 7-day average instantaneous morning (AM) diary symptom scores (ADS7-IA); and
2) reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 as determined by a nasal polyp grading scale score measured using a 0 to 6 point severity grading scale (with 0 to 3 points per nostril).
Male or female subjects aged 12 to 17 years, inclusive
Must have bilateral nasal polyposis
Must report at least mild symptoms of nasal congestion/obstruction