Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With… (NCT03960580) | Clinical Trial Compass
CompletedPhase 3
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps
United States223 participantsStarted 2019-06-06
Plain-language summary
This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic Rhinosinusitis (CRS) without nasal polyps
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. men or women aged 18 years and older at baseline visit
✓. women of child bearing potential must be abstinent, or if sexually active,
✓. be practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[eg, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel\], 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 (Screening)
✓. must have a history of chronic sinusitis and be currently experiencing 2 or more of the following symptoms, 1 of which has to be either nasal congestion or nasal discharge (anterior and/or posterior nasal discharge) for equal to or greater than 12 weeks:
✓. endoscopic evidence of nasal mucosal disease, with edema or purulent discharge; or polyps/polypoid tissue \<Grade 1 in middle meatus, bilaterally
Exclusion criteria
✕. women who are pregnant or lactating
✕. inability to have each nasal cavity examined for any reason, including nasal septum deviation
What they're measuring
1
Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4
Timeframe: 4 Weeks
2
Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified (APOV) in the Ethmoid and Maxillary Sinuses.
✕. have previously used XHANCE® for more than 1 month and did not achieve an adequate symptomatic response
✕. the nasal/sinus anatomy prevents the accurate assessment of sinus volume via CT scan
✕. history of sinus or nasal surgery within 6 months before Visit 1 or has not healed from a prior sinus or nasal surgery
✕. have current evidence of odontogenic sinusitis, sinus mucocele (the affected sinus is completely opacified and either the margins are expanded and/or thinned OR there are areas of complete bone resorption resulting in bony defect and extension of the "mass" into adjacent tissues), evidence of allergic fungal sinusitis, or evidence of complicated sinus disease (including, but not limited to, extension of inflammation outside of the sinuses and nasal cavity)