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Phase III

Efficacy and Safety of OPN-375 186 ug Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps

  • Study HIC#:2000023985
  • Last Updated:07/15/2021

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
  • GenderBoth
  • Start Date04/29/2019
  • End Date12/31/2018

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).

Eligibility Criteria

Eligibility criteria 

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

 

Principal Investigator

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