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NCT03747458 · ClinicalTrials.gov registry record · Phase 3
OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps
A Phase 3 study of Bilateral Nasal Polyposis, sponsored by Optinose US.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT03747458 is a Phase 3 study of Bilateral Nasal Polyposis that is actively recruiting participants, run by Optinose US. The registered enrollment target is 72 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT03747458, a Phase 3 study of Bilateral Nasal Polyposis, is actively recruiting participants, sponsored by Optinose US.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG OPN-375
Study Locations (20)
California
- Kern Research - Bakersfield
- Central California Clinical Research - Fresno
- Sensa Health - Los Angeles
- Children's Hospital of Los Angeles - Los Angeles
- Children's Hospital of Orange County - Orange
- Allergy and Asthma Consultants - Redwood City
- Sacramento ENT - Roseville
- Rady Children's Hospital San Diego - San Diego
Illinois
- Rush University Medical Center - Department of Otorhinolaryngology - Chicago
- Chicago ENT - Chicago
Alabama
- Clinical Research Center of Alabama - Birmingham
Arizona
- San Tan Allergy & Asthma - Gilbert
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Yale School of Medicine, Section of Otolaryngology - New Haven
Florida
- Nemours Children's Specialty Care - Jacksonville
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2018-12-31 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03747458
The ClinicalTrials.gov registry entry for NCT03747458 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Optinose US, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bilateral Nasal Polyposis appearing as the primary indexed condition, and to 1 intervention - of which OPN-375 is the first listed.
NCT03747458 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Illinois, Alabama.
Frequently Asked Questions
What is clinical trial NCT03747458 about?
NCT03747458 is a clinical study titled "OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps". 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 i...
What is the current status of trial NCT03747458?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2018-12-31. Estimated completion is 2026-03.
What conditions does trial NCT03747458 study?
This clinical trial studies the following conditions: Bilateral Nasal Polyposis.
What interventions are being tested in trial NCT03747458?
The interventions under investigation include: OPN-375 (DRUG).
Who is sponsoring clinical trial NCT03747458?
This trial is sponsored by Optinose US, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03747458 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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