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Completed

NCT Number: NCT05553366

Evaluation of 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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shoals Medical Trials Inc., Sheffield, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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.

Treatment and study plan

SUZ

Drug

Tablets for oral administration.

Other names: VX-548

HB/APAP

Drug

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.

Primary outcomes

  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

    Time frame: 0 to 48 hours After First Dose of Study Drug

    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).

Secondary outcomes

  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

    Time frame: 0 to 48 hours After First Dose of Study Drug

    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).

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

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

    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.

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

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

    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.

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

    Time frame: At 48 Hours After First Dose of Study Drug

    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.

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

    Time frame: From Baseline up to Day 19

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

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

    Time frame: 0 to 24 Hours After First Dose of Study Drug

    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).

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

    Time frame: 0 to 48 Hours After First Dose of Study Drug

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

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

    Time frame: 0 to 48 Hours After First Dose of Study Drug

  9. Total Rescue Medication Usage, SUZ Compared to Placebo

    Time frame: 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)

    Time frame: Day 1 up to Day 19

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2022
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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