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| ID | Type | Description | Link |
|---|---|---|---|
| C4951015 | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rimegepant 75 mg ODT | Active Comparator | One dose of rimegepant 75 mg ODT |
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| Matching Placebo | Active Comparator | One dose of matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rimegepant 75 mg ODT | Drug | One dose of rimegepant 75 mg ODT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Clinical Research Center | La Mesa | California | 91942 | United States | ||
| Velocity Clinical San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41779821 | Derived | Franjic D, Fountaine RJ, Nalpas C, Goswami B, Fullerton T. Efficacy and safety of rimegepant 75 mg orally disintegrating tablet for the acute treatment of chronic rhinosinusitis in adults: Results from a multicenter, randomized, placebo-controlled, phase 2/3 trial. PLoS One. 2026 Mar 4;21(3):e0342907. doi: 10.1371/journal.pone.0342907. eCollection 2026. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Participants were to administer one dose of study medication only when participant had a facial pain/pressure/fullness that reached intensity of greater than or equal to (>=) 6 on the numeric rating scale (NRS, 0 to 10) and they had completed pre-dose assessments in electronic (e)-diary. Study medication was to be administered only within 45 days of randomization.
A total of 261 participants were enrolled and randomized in the study. Amongst which 99 received rimegepant and 105 received placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rimegepant 75 mg | Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an orally disintegrating tablet (ODT) sublingually. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2023 | Mar 5, 2025 |
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| Matching placebo |
| Drug |
One dose of matching placebo |
|
| 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. | 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. | 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). | 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. | Through 24 hours post-dose |
| La Mesa |
| California |
| 91942 |
| United States |
| National Research Institute | Panorama City | California | 91402 | United States |
| Sacramento Ear Nose and Throat Surgical and Medical Group, Inc. | Roseville | California | 95628 | United States |
| Sharp & Children's MRI Center, LLC (CT scan) | San Diego | California | 92123 | United States |
| Breathe Clear Institute | Torrance | California | 90503 | United States |
| Colorado ENT & Allergy | Colorado Springs | Colorado | 80923 | United States |
| Velocity Clinical Research, New Smyrna Beach | Edgewater | Florida | 32132 | United States |
| The Medici Medical Research, LLC | Hollywood | Florida | 33021 | United States |
| Avantis Clinical Research | Miami | Florida | 33155 | United States |
| Clinovation Research | Pompano Beach | Florida | 33064 | United States |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | United States |
| ChicagoENT | Chicago | Illinois | 60657 | United States |
| Kentuckiana Ear, Nose & Throat | Louisville | Kentucky | 40205 | United States |
| Best Clinical Trials, LLC (Administrative Only) | New Orleans | Louisiana | 70115 | United States |
| George Stanley Walker, MD | New Orleans | Louisiana | 70115 | United States |
| University of Missouri Hospital & Clinics, ENT & Allergy Center of Missouri | Columbia | Missouri | 65201 | United States |
| University of Missouri Healthcare - Investigational Pharmacy | Columbia | Missouri | 65212 | United States |
| University of Missouri Hospital (Radiology) | Columbia | Missouri | 65212 | United States |
| Clinvest Research, LLC | Springfield | Missouri | 65810 | United States |
| St Charles Clinical Research | Weldon Spring | Missouri | 63304 | United States |
| Northwell Health Department of Otolaryngology | New Hyde Park | New York | 11042 | United States |
| Tekton Research, Inc. | Edmond | Oklahoma | 73013 | United States |
| Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| Velocity Clinical Research, Grants Pass | Grants Pass | Oregon | 97527 | United States |
| Velocity Clinical Research, Medford | Medford | Oregon | 97504 | United States |
| Velocity Clinical Research, Anderson | Anderson | South Carolina | 29621 | United States |
| Carolina ENT Clinic/CENTRI Inc. | Orangeburg | South Carolina | 29118 | United States |
| Spokane Ear, Nose & Throat/ Columbia Surgical Specialists | Spokane | Washington | 99201 | United States |
| Principle Research Solutions | Spokane | Washington | 99204 | United States |
| Spokane Ear, Nose & Throat / Columbia Surgical Specialists | Spokane | Washington | 99216 | United States |
| Allergy, Asthma & Sinus Center, S.C. | Greenfield | Wisconsin | 53228 | United States |
Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually.
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rimegepant 75 mg | Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an ODT sublingually. |
| BG001 | Placebo | Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intent to Treat (mITT) analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of >= 6 on the NRS (0-10) prior to administration of treatment and provided at least one post-baseline efficacy data point in the e-diary. All assessments after rescue medication administration were set to missing. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline, 2 hours post-dose |
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| Secondary | 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. | mITT analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of >= 6 on the NRS (0-10) prior to administration of treatment and provided at least one post-baseline efficacy data point in the e-diary. All assessments after rescue medication administration were set to missing. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline, 2 hours post-dose |
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| Secondary | 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. | mITT analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of >=6 on the NRS (0-10) prior to administration of treatment and provide at least one post-baseline efficacy data point in the e-diary. All assessments after rescue medication administration were set to missing. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline, 2 hours post-dose |
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| Secondary | 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. | mITT analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of >= 6 on the NRS (0-10) prior to administration of treatment and provide at least one post-baseline efficacy data point in the e-diary. All assessments after rescue medication administration were set to missing. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline, 2 hours post-dose |
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| Secondary | 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). | mITT analysis set analyzed. Participants who reported a headache pain level of moderate or severe intensity at baseline were assessed. Participants who had missing data at 2 hours post-dose, or who took rescue medication at or before 2 hours post-dose were imputed as failures. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 2 hours post-dose |
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| Secondary | 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. | mITT analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of greater than or equal to (>=) 6 on the NRS (0-10) prior to administration of treatment and provided at least one post-baseline efficacy data point in the e-diary. Participants who recorded rescue medication use within 24 hours post-dose were considered failures, where failure was the event being analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through 24 hours post-dose |
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Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization)
Safety analysis set was evaluated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rimegepant | Participants received one dose of Rimegepant at a dose of 75 mg, orally, as an ODT for the acute treatment of CRS with or without nasal polyps. | 0 | 99 | 0 | 99 | 4 | 99 |
| EG001 | Placebo | Participants received one dose of Rimegepant matching placebo, orally, as an ODT for the acute treatment of CRS with or without nasal polyps. | 0 | 105 | 0 | 105 | 5 | 105 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Electrocardiogram PR shortened | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 14, 2024 | Mar 5, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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