OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps (NCT03747458) | Clinical Trial Compass
Active — Not RecruitingPhase 3
OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps
United States72 participantsStarted 2018-12-31
Plain-language 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.
Who can participate
Age range12 Years – 17 Years
SexALL
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Inclusion criteria
✓. 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.)
Exclusion criteria
✕. Pregnancy or lactation
What they're measuring
1
Change in nasal congestion/obstruction symptoms (mild, moderate, severe) at the end of Week 4
Timeframe: 4 Weeks
2
Mean change from baseline at Week 16 in total polyp grade
✕. Have used XHANCE (fluticasone propionate) nasal spray within the past 2 months
✕. Inability to achieve bilateral nasal airflow for any reason, including nasal septum deviation
✕. Inability to examine both nasal cavities for any reason, including severe nasal septum deviation
✕. Have known history of nasal septum erosion, ulceration or perforation, or evidence of such lesion on Visit 1 (Screening) nasal examination/nasoendoscopy
✕. Other significant nasal pathology or abnormal anatomy
✕. Has had any episode of epistaxis with frank bleeding in the 3 months before Visit 1 (Screening)