Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis
- Conditions
- Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
- Interventions
- Drug: Matching placebo
- Registration Number
- NCT05248997
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- At least two episodes of facial pain/pressure/fullness of moderate or severe intensity on a 4-point rating scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) in the past 30 days prior to the Screening Visit.
- Subject agrees to study-required medication restrictions and the restriction of not starting new medication to treat CRS symptoms during the course of the study.
- Subject agrees to study-required birth control methods during the course of the study, and female subjects must not be breastfeeding.
- No clinically significant abnormality identified on the medical or laboratory evaluation.
- Subject has primary headache disorder.
- Subject has history of nasal or facial surgery within the 6 months prior to screening.
- Subject has ongoing rhinitis medicamentosa.
- Subject has diagnosed or suspected invasive fungal rhinosinusitis.
- Subject is currently receiving aspirin desensitization or maintenance therapy for Samter's Triad.
- Subject has a history of recurrent acute sinusitis (four or more episodes per year of acute bacterial rhinosinusitis (ABRS) without signs or symptoms of rhinosinusitis between episodes).
- Body Mass Index > 35.0kg/m2
- Subject history of exclusionary medical conditions such as HIV disease, cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatric conditions, drug or alcohol abuse, malignancies, drug allergies, or any significant and/or unstable medical conditions.
- Subjects taking/using excluded therapies.
- Participation in clinical trial with non-biological investigational agents or investigational interventional treatments.
- Subjects who have previously participated in any BHV-3000/ BMS-927711/ rimegepant study.
- Planned participation in any other investigational clinical trial while participating in this clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rimegepant 75 mg ODT rimegepant 75 mg ODT One dose of rimegepant 75 mg ODT Matching Placebo Matching placebo One dose of matching placebo
- Primary Outcome Measures
Name Time Method Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose Baseline, 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose Baseline, 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.
Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose Baseline, 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.
Change From Baseline in Nasal Discharge at 2 Hours Post-Dose Baseline, 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.
Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose 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).
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose Through 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.
Trial Locations
- Locations (33)
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
Clinovation Research
🇺🇸Pompano Beach, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
ChicagoENT
🇺🇸Chicago, Illinois, United States
Kentuckiana Ear, Nose & Throat
🇺🇸Louisville, Kentucky, United States
Best Clinical Trials, LLC (Administrative Only)
🇺🇸New Orleans, Louisiana, United States
George Stanley Walker, MD
🇺🇸New Orleans, Louisiana, United States
University of Missouri Hospital & Clinics, ENT & Allergy Center of Missouri
🇺🇸Columbia, Missouri, United States
University of Missouri Healthcare - Investigational Pharmacy
🇺🇸Columbia, Missouri, United States
University of Missouri Hospital (Radiology)
🇺🇸Columbia, Missouri, United States
Clinvest Research, LLC
🇺🇸Springfield, Missouri, United States
St Charles Clinical Research
🇺🇸Weldon Spring, Missouri, United States
Northwell Health Department of Otolaryngology
🇺🇸New Hyde Park, New York, United States
Tekton Research, Inc.
🇺🇸Edmond, Oklahoma, United States
Allergy, Asthma & Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
Velocity Clinical Research, Grants Pass
🇺🇸Grants Pass, Oregon, United States
Velocity Clinical Research, Medford
🇺🇸Medford, Oregon, United States
Velocity Clinical Research, Anderson
🇺🇸Anderson, South Carolina, United States
Carolina ENT Clinic/CENTRI Inc.
🇺🇸Orangeburg, South Carolina, United States
Spokane Ear, Nose & Throat/ Columbia Surgical Specialists
🇺🇸Spokane, Washington, United States
Principle Research Solutions
🇺🇸Spokane, Washington, United States
Spokane Ear, Nose & Throat / Columbia Surgical Specialists
🇺🇸Spokane, Washington, United States
Allergy, Asthma & Sinus Center, S.C.
🇺🇸Greenfield, Wisconsin, United States