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

Who is this study for? Adolescents with bilateral nasal polyps
What treatments are being studied? OPN-375
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• Male or female subjects aged 12 to 17 years, inclusive, at time of Visit 1 (Screening).

• Female subjects, if sexually active, must,

∙ be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel\], or male partner sterilization) before entry and throughout the study, or

‣ be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or

‣ be abstinent.

• All female subjects not documented to be infertile (e.g., infertility due to congenital abnormality or surgical sterilization) must have a negative serum or urine beta-human chorionic gonadotropin (hCG) at Visit 1 (Screening) and a negative urine pregnancy test at the Visit 2 (Day 1/Randomization/Baseline).

• Must have bilateral nasal polyposis with a grade of 1 to 3 in each of the nasal cavities as determined by a nasal polyp grading scale score measured by nasoendoscopy at Visit 1 (Screening).

• Must report at least mild symptoms of nasal congestion/obstruction as demonstrated by an average morning nasal congestion/obstruction score of at least 1.0 over a 7 day period during the single-blind run-in period. (Subjects not meeting this inclusion criterion may be re-screened once after at least 4 weeks.)

• Subjects with comorbid asthma must be stable, defined as no exacerbations (e.g., no emergency room visits, hospitalization, or oral or parenteral steroid use) within the 3 months before Visit 1 (Screening). Subjects who received inhaled corticosteroids are required to be on no more than a moderate dosage regimen as defined by 2015 Global Initiative for Asthma Guidelines (GINA) for 1 month before Visit 1 (Screening) and to be expected to remain on it throughout the study (GINA 2015). Subjects receiving inhaled fluticasone alone or in combination may not participate in the PK sub-study.

• Must be able to cease treatment with intranasal medications including, but not limited to, intranasal oxymetazoline or any other decongestants, intranasal antihistamines, intranasal steroids, intranasal sodium cromolyn, nasal atropine, nasal ipratropium bromide, inhaled corticosteroids (except permitted doses listed above for asthma) at Visit 1 (Screening). \[Note: intranasal antibiotics and saline are permissible\]

• If taking oral antihistamines, must be on a stable regimen for at least 2 weeks prior to Visit 1 (Screening), and agree to not change the dose of these medications until after Visit 3 (Week 4) of the study.

• Subjects (with assistance from parent or legal guardian if needed) must demonstrate the ability to complete the daily diary during the run-in period to be eligible for randomization.

⁃ Must demonstrate correct use of the demo EDS.

⁃ Must be capable, in the opinion of the investigator, of providing assent and the appropriate parent(s) or guardian must provide an informed consent to participate in the study.

Locations
United States
Alabama
Clinical Research Center of Alabama
WITHDRAWN
Birmingham
Arizona
San Tan Allergy & Asthma
COMPLETED
Gilbert
California
Kern Research
COMPLETED
Bakersfield
Central California Clinical Research
COMPLETED
Fresno
Children's Hospital of Los Angeles
RECRUITING
Los Angeles
Sensa Health
RECRUITING
Los Angeles
Children's Hospital of Orange County
RECRUITING
Orange
Allergy and Asthma Consultants
RECRUITING
Redwood City
Sacramento ENT
RECRUITING
Roseville
Rady Children's Hospital San Diego
RECRUITING
San Diego
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Connecticut
Yale School of Medicine, Section of Otolaryngology
WITHDRAWN
New Haven
Florida
Nemours Children's Specialty Care
WITHDRAWN
Jacksonville
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Illinois
Chicago ENT
RECRUITING
Chicago
Rush University Medical Center - Department of Otorhinolaryngology
WITHDRAWN
Chicago
Kentucky
Kentuckiana ENT
RECRUITING
Louisville
Louisiana
Ochsner Medical Center, Otorhinolaryngology Department
WITHDRAWN
New Orleans
Minnesota
Children's Minnesota
WITHDRAWN
Minneapolis
Missouri
University of Missouri Medical Center
RECRUITING
Columbia
North Carolina
Allergy Asthma & Immunology Research Institute
RECRUITING
Charlotte
New York
University of Rochester
RECRUITING
Rochester
Oklahoma
Allergy, Asthma & Clinical Research Center
RECRUITING
Oklahoma City
Vital Prospects Clinical Research Institute, P.C.
RECRUITING
Tulsa
South Carolina
MUSC Department of Otolaryngology, Head and Neck Surgery
WITHDRAWN
Charleston
Carolina ENT
RECRUITING
Orangeburg
Texas
STAAMP Research
RECRUITING
San Antonio
Utah
University of Utah
COMPLETED
Salt Lake City
Virginia
Eastern Virginia Medical School - Otolaryngology
RECRUITING
Norfold
Washington
Spokane ENT
COMPLETED
Spokane Valley
West Virginia
West Virginia University
WITHDRAWN
Morgantown
Other Locations
Argentina
Fundacion CIDEA
RECRUITING
Buenos Aires
InAER - Investigaciones en Alergia y Enfermedades Respiratorias
RECRUITING
Buenos Aires
Sanatorio Guemes
RECRUITING
Buenos Aires
Instituto de Asma Alergia y Enfermedades Respiratoria (IAAER)
RECRUITING
Corrientes
Centro Medico INSARES
RECRUITING
Mendoza
Instituto Medico Rio Cuarto
RECRUITING
Río Cuarto
Centro de Investigaciones Clinicas - Instituto de la Salud Rosario
RECRUITING
Rosario
Instituto Medico de la Fundacion de Estudios Clinicos - Consultorios Integrados Rosario
RECRUITING
Rosario
Clinica Mayo, UMCB
RECRUITING
San Miguel De Tucumán
Contact Information
Primary
Alissa Sirbu
alissa.sirbu@paratekpharma.com
484-751-4926
Backup
Amy Manley
amy.manley@paratekpharma.com
Time Frame
Start Date: 2018-12-31
Estimated Completion Date: 2026-03
Participants
Target number of participants: 72
Treatments
Active_comparator: OPN-375 186 μg BID
Double-Blind Treatment Phase: OPN-375 186 μg BID x 16 weeks~Open-Label Extension Phase: OPN-375 186 μg BID x 12 weeks
Placebo_comparator: Placebo
Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks
Related Therapeutic Areas
Sponsors
Leads: Optinose US Inc.

This content was sourced from clinicaltrials.gov

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