The purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of chronic rhinosinusitis (CRS) with and without nasal polyps.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
261
One dose of rimegepant 75 mg ODT
One dose of matching placebo
Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose
Facial pain/pressure/fullness was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no facial pain/pressure/fullness" and 10 being "worst imaginable facial pain/pressure/fullness." Higher scores signified worse condition.
Time frame: Baseline, 2 hours post-dose
Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose
TNSS was calculated as the sum of 3 symptom scores: facial pain/pressure/fullness, score ranged from 0 (no facial pain/pressure/fullness) to 10 (worst imaginable facial pain/pressure/fullness); nasal obstruction (congestion), score ranged from 0 (no nasal obstruction (congestion) to 10 (worst imaginable nasal obstruction (congestion); and nasal discharge, score ranged from 0 (no nasal discharge) to 10 (worst nasal discharge). TNSS overall score ranged from 0 (no nasal symptom) to 30 (worst nasal symptom); higher scores signified worse condition.
Time frame: Baseline, 2 hours post-dose
Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose
Nasal obstruction (congestion) severity was assessed using a NRS ranging in integers from 0 (no nasal obstruction \[congestion\]) to 10 (worst imaginable nasal obstruction \[congestion\]). Higher scores signified worse condition.
Time frame: Baseline, 2 hours post-dose
Change From Baseline in Nasal Discharge at 2 Hours Post-Dose
Nasal discharge severity was assessed using a NRS ranging in integers from 0 (no nasal discharge) to 10 (worst imaginable nasal discharge). Higher scores signified worse condition.
Time frame: Baseline, 2 hours post-dose
Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose
Headache pain relief was defined as a headache pain level of none or mild at 2 hours post-dose on a 4-point Likert scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe).
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San Diego Clinical Research Center
La Mesa, California, United States
Velocity Clinical San Diego
La Mesa, California, United States
National Research Institute
Panorama City, California, United States
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
Roseville, California, United States
Sharp & Children's MRI Center, LLC (CT scan)
San Diego, California, United States
Breathe Clear Institute
Torrance, California, United States
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, United States
The Medici Medical Research, LLC
Hollywood, Florida, United States
Avantis Clinical Research
Miami, Florida, United States
...and 23 more locations
Time frame: 2 hours post-dose
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose
Post 2 hours after dosing with study medication and after the 2-hour assessments were completed on the e-diary, participants were permitted to use the following rescue medications (non-study medications) such as: acetaminophen or aspirin, ibuprofen, naproxen (or any other type of nonsteroidal anti-inflammatory drug \[NSAID\]), oral antihistamines (non- sedating), oral decongestants, topical nasal decongestants, topical nasal anticholinergics.
Time frame: Through 24 hours post-dose