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Bilateral Nasal Polyposis clinical trials

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NCT ID: NCT03747458 Recruiting - Clinical trials for Bilateral Nasal Polyposis

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

Start date: December 31, 2018
Phase: Phase 3
Study type: Interventional

This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg 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 μg: Placebo). For the PK sub-study, up to 14 subjects will be enrolled to obtain 10 completers.