OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps
Public ClinicalTrials.gov record NCT03747458. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
16-Week Randomized Double-Blind Placebo Controlled Parallel-Group Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day in Adolescents With Bilateral Nasal Polyps Followed With 12-Week Open-Label Treatment Phase
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03747458
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2018 (Actual)
- Primary completion
- Mar 31, 2026 (Actual)
- Completion
- Jun 11, 2026 (Actual)
- Last update posted
- Sep 18, 2026
2018 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| San Tan Allergy & Asthma | Gilbert | Arizona | 85234 | — |
| Kern Research | Bakersfield | California | 93301 | — |
| Central California Clinical Research | Fresno | California | 93720 | — |
| Sensa Health | Los Angeles | California | 90006 | — |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Allergy and Asthma Consultants | Redwood City | California | 94063 | — |
| Sacramento ENT | Roseville | California | 95661 | — |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Chicago ENT | Chicago | Illinois | 60657 | — |
| Kentuckiana ENT | Louisville | Kentucky | 40205 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Allergy Asthma & Immunology Research Institute | Charlotte | North Carolina | 28204 | — |
| Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | — |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | — |
| Carolina ENT | Orangeburg | South Carolina | 29118 | — |
| STAAMP Research | San Antonio | Texas | 78229 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Eastern Virginia Medical School - Otolaryngology | Norfolk | Virginia | 23507 | — |
| Spokane ENT | Spokane Valley | Washington | 99216 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03747458, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2026 · Synced Nov 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03747458 live on ClinicalTrials.gov.