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Acute PainPhase 3NCT05553366

Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

A Phase 3 study testing SUZ and HB/APAP in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Pain
What is being tested?
SUZ and HB/APAP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,075 participants
Where
21 sitesUnited States
Study dates
3 Oct 2022to 15 Dec 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Before Surgery
  • Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)
  • After Surgery
  • Participant is lucid and able to follow commands
  • All analgesic guidelines were followed during and after the bunionectomy

Who cannot join

  • Before Surgery
  • Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot
  • History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
  • Any prior surgery within 1 month before the first study drug dose
  • After Surgery
  • Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
  • Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Trovare Clinical Research

    Bakersfield, California, 93301

  • HD Research LLC | First Surgical Hospital

    Bellaire, Texas, 77401

  • HD Research LLC | Legent Orthopedic Hospital

    Carrollton, Texas, 75006

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Clinical Pharmacology of Miami

    Hialeah, Florida, 33014

  • HD Research LLC | Houston Heights Hospital

    Houston, Texas, 77008

  • Center for Orthopaedic Reconstruction and Excellence

    Jenks, Oklahoma, 74037

  • Woodland International Research Group

    Little Rock, Arkansas, 72211

  • Futuro Clinical Trials

    McAllen, Texas, 78501

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • JBR Clinical Research

    Salt Lake City, Utah, 84107

  • Endeavor Clinical Trials

    San Antonio, Texas, 78240

  • Pacific Research Network Inc

    San Diego, California, 92103

  • Shoals Medical Trials Inc.

    Sheffield, Alabama, 35660

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • New Hope Research Development

    Tarzana, California, 91356

  • Houston Physicians Hospital

    Webster, Texas, 77598

  • New Hope Research Development

    West Covina, California, 91790

  • Kansas Spine and Specialty Hospital

    Wichita, Kansas, 67226

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.

Conditions
Acute Pain
Being tested
SUZ, HB/APAP, Placebo (matched to SUZ), Placebo (matched to HB/APAP)
Medical subject headings
Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUZDrug

    Also called VX-548

    Tablets for oral administration.

  • HB/APAPDrug

    Capsules for oral administration.

  • Placebo (matched to SUZ)Drug

    Placebo matched to SUZ for oral administration.

  • Placebo (matched to HB/APAP)Drug

    Placebo matched to HB/APAP for oral administration.

Study groups in NCT05553366
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
Receives: Drug: Placebo (matched to SUZ); Drug: Placebo (matched to HB/APAP)
Hydrocodone bitartrate/acetaminophen (HB/APAP)Active comparatorParticipants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.
Receives: Drug: HB/APAP; Drug: Placebo (matched to SUZ)
Suzetrigine (SUZ)ExperimentalParticipants received SUZ [100 mg as first dose, followed by 50 mg every 12 hours (q12h)] for 2 days.
Receives: Drug: SUZ; Drug: Placebo (matched to HB/APAP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to Placebo

    SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated subtracting the baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).

    Measured: 0 to 48 hours After First Dose of Study Drug

Secondary outcomes (10)

  1. Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to HB/APAP

    SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point(using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).

    Measured: 0 to 48 hours After First Dose of Study Drug

  2. Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo

    Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.

    The time to ≥ 2-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 2-point reduction in NPRS scores from baseline.

    Measured: From Baseline Up to 48 Hours After First Dose of Study Drug

  3. Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo

    Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.

    The time to ≥1-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 1-point reduction in NPRS from baseline.

    Measured: From Baseline Up to 48 Hours After First Dose of Study Drug

  4. Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo

    The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 4-point Likert scale as: (poor, fair, good, or excellent). Percentage of participants who reported good or excellent on the PGA scale were reported.

    Measured: At 48 Hours After First Dose of Study Drug

  5. Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP

    The percentage of participants with the events of vomiting or nausea during the specified time frame was reported.

    Measured: From Baseline up to Day 19

  6. Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo

    SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).

    Measured: 0 to 24 Hours After First Dose of Study Drug

  7. Time to First Use of Rescue Medication, SUZ Compared to Placebo

    Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication.

    Measured: 0 to 48 Hours After First Dose of Study Drug

  8. Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo

    Measured: 0 to 48 Hours After First Dose of Study Drug

  9. Total Rescue Medication Usage, SUZ Compared to Placebo

    Measured: 0 to 48 Hours After First Dose of Study Drug

  10. Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Day 1 up to Day 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2022
  2. Study start3 Oct 2022
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,075 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05553366
Sponsor's protocol ID
VX22-548-104
Status last verified
Jul 2025
First submitted
20 Sep 2022
Last updated
1 Aug 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SUZ and HB/APAP in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to Placebo (time frame: 0 to 48 hours After First Dose of Study Drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05553366.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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