Phase 3 Chronic Rhinosinusitis Trial, Completed NCT05248997 Sponsor: Pfizer Condition: Chronic Rhinosinusitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT05248997) enrolled 261 people in total — 131 assigned to receive a 75 mg dose of rimegepant and 130 assigned to receive a placebo (a dummy treatment with no active ingredient). Of those, 99 in the rimegepant group and 105 in the placebo group actually received their assigned treatment, and 98 and 104 respectively completed the study. The trial was measuring symptoms of acute sinusitis (sinus pain, pressure, nasal congestion and discharge) using rating scales where participants scored their symptoms from 0 (none) to 10 (worst imaginable), and also looked at headache relief and use of additional pain relief medication within 24 hours. The reported data shows that for the primary outcome — change in facial pain/pressure/fullness two hours after taking the treatment — participants in the rimegepant group reported an average reduction of 2.70 points on the 0–10 scale, while those in the placebo group reported an average reduction of 2.61 points. For the combined nasal symptom score (a 0–30 scale adding up pain, congestion and discharge), the rimegepant group reported an average drop of 7.04 points compared with 6.74 points in the placebo group. Looking at individual symptoms at two hours, nasal congestion decreased by an average of 2.48 points (rimegepant) versus 2.25 points (placebo), and nasal discharge decreased by 1.81 points (rimegepant) versus 1.85 points (placebo). For headache relief at two hours, 59.4% of people in the rimegepant group and 55.6% in the placebo group reported their headache pain had reached a "none" or "mild" level. Regarding rescue medication use in the 24 hours after dosing, 7.3% of the rimegepant group and 10.0% of the placebo group reported taking additional pain relief. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Chronic Rhinosinusitis Trial, Completed

NCT05248997
Completed Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have had at least two episodes of moderate or severe facial pain, pressure, or fullness in the past 30 days before the screening visit.
  • You are willing to follow the study's rules about which medications you can take and agree not to start any new medications for sinus symptoms during the study.
  • You are willing to use the study's required birth control methods during the study, and if you are a woman, you are not currently breastfeeding.
  • You do not have any significant abnormal results from your medical or lab tests at screening.

Who may not be able to join:

  • You have a primary headache disorder (such as migraines or tension headaches as a main diagnosis).
  • You have had surgery on your nose or face in the last 6 months before screening.
  • You currently have rebound nasal congestion caused by overuse of nasal decongestant sprays (confirm with trial site).
  • You have been diagnosed with, or are suspected of having, an invasive fungal sinus infection.
  • You are currently receiving aspirin desensitization or ongoing aspirin therapy for Samter's Triad (a condition involving aspirin sensitivity, asthma, and nasal polyps).
  • You have a history of getting four or more separate bacterial sinus infections per year, with no sinus symptoms between those episodes.
  • Your Body Mass Index (BMI) is higher than 35.
  • You have a history of certain serious health conditions, including HIV, heart or blood vessel disease, uncontrolled high blood pressure or diabetes, psychiatric conditions, drug or alcohol misuse, cancer, significant drug allergies, or other major unstable health conditions.
  • You are currently taking or using any medications or treatments that are not allowed by the study.
  • You are currently taking part in another clinical trial involving an experimental (non-biological) treatment or procedure.
  • You have previously taken part in a study involving the drug BHV-3000, BMS-927711, or rimegepant.
  • You are planning to join another investigational clinical trial at the same time as this one.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
17 February 2022
Est. completion
11 March 2024

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov