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NCT05248997 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis
A Phase 3 study of Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 261
- Enrollment target
- 20
- Study locations
NCT05248997: Completed Phase 3 study of Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, sponsored by Pfizer.
NCT05248997 is a Phase 3 study of Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps that has completed, run by Pfizer. The registered enrollment target is 261 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05248997, a Phase 3 study of Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 261 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Matching placebo
- DRUG rimegepant 75 mg ODT
Study Locations (20)
California
- San Diego Clinical Research Center - La Mesa
- Velocity Clinical San Diego - La Mesa
- National Research Institute - Panorama City
- Sacramento Ear Nose and Throat Surgical and Medical Group, Inc. - Roseville
- Sharp & Children's MRI Center, LLC (CT scan) - San Diego
- Breathe Clear Institute - Torrance
Florida
- Velocity Clinical Research, New Smyrna Beach - Edgewater
- The Medici Medical Research, LLC - Hollywood
- Avantis Clinical Research - Miami
- Clinovation Research - Pompano Beach
Missouri
- University of Missouri Hospital & Clinics, ENT & Allergy Center of Missouri - Columbia
- University of Missouri Healthcare - Investigational Pharmacy - Columbia
- University of Missouri Hospital (Radiology) - Columbia
- Clinvest Research, LLC - Springfield
Louisiana
- Best Clinical Trials, LLC (Administrative Only) - New Orleans
- George Stanley Walker, MD - New Orleans
Colorado
- Colorado ENT & Allergy - Colorado Springs
Idaho
- Treasure Valley Medical Research - Boise
Illinois
- ChicagoENT - Chicago
Kentucky
- Kentuckiana Ear, Nose & Throat - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2022-02-17 |
| Est. Completion | 2024-04-02 |
| Phase | Phase 3 |
What the finished NCT05248997 record still lists
NCT05248997 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps appearing as the primary indexed condition, and to 2 interventions - of which Matching placebo is the first listed.
NCT05248997 names 20 study sites across 8 states, led by California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT05248997 about?
NCT05248997 is a clinical study titled "Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis". 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.
What is the current status of trial NCT05248997?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 261 participants. The study started on 2022-02-17. Estimated completion is 2024-04-02.
What conditions does trial NCT05248997 study?
This clinical trial studies the following conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps.
What interventions are being tested in trial NCT05248997?
The interventions under investigation include: Matching placebo (DRUG), rimegepant 75 mg ODT (DRUG).
Who is sponsoring clinical trial NCT05248997?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05248997 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05248997's enrollment target sits among peer trials
261 1228th of 2000 higher than 771 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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