Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video (NCT03591068) | Clinical Trial Compass
CompletedPhase 3
Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video
United States11 participantsStarted 2018-06-07
Plain-language summary
This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The total planned number of subjects is approximately 10, with each subject receiving OPN-375 186 μg twice a day.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men or women aged 18 years and older at Visit 1 (Baseline/Day1)
✓. Women of child bearing potential must be abstinent, or if sexually active,
✓. 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 postmenopausal (amenorrhea for at least 1 year).
✓. Women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Day 1/Baseline)
✓. Must have bilateral nasal polyposis with a grade of 2 or 3 in at least one side of the nasal cavity as determined by a nasal polyp grading scale score measured by nasoendoscopy at Visit 1 (Day 1/Baseline)
✓. Must have a SNOT-22 score of ≥20 at Visit 1(Baseline/Day 1)
Exclusion criteria
✕. Women who are pregnant or lactating
✕. Inability to have each nasal cavity examined for any reason, including nasal septum deviation
✕. Have used XHANCE™ (fluticasone propionate) nasal spray within the past 2 months
What they're measuring
1
Change From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video