Last updated on July 2019

OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps

Brief description of study

This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 g Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. The total planned number of subjects is approximately 120 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 2:1 ratio (OPN-375 186 g: Placebo). For the PK sub-study, up to 14 subjects will be enrolled to obtain 10 completers.

Detailed Study Description

The primary objective of this study is 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 by analyzing the reduction of nasal congestion/obstruction symptoms at the end of Week 4 measured by the 7-day average instantaneous morning diary symptom scores and the reduction in total polyp grade at Week 16 as determined by a nasal polyp grading scale score measured using a 0 to 6 point severity grading scale.

Clinical Study Identifier: NCT03747458

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