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

Completed · Phase 3 · NCT03747458

Conditions: Bilateral Nasal Polyposis

At a glance

Research payments reported, 2025
$10,164
U.S. investigators named
4
Sites paid
6
Planned or actual enrollment
40

About the trial

Sponsor
Optinose US Inc. (with Paratek Pharmaceuticals Inc)
Tested
OPN-375 (drug)
Dates
Started 2018-12-31; completion 2026-06-11
Results posted
Not yet

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 72 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.

From ClinicalTrials.gov, last updated 2026-09-18. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Paratek Pharmaceuticals, Inc. reported $10,164 in research payments for this study in 2025 (9 payments).

Products named: Xhance

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.