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

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 VX-548 for acute pain after a bunionectomy.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: VX-548; Drug: Placebo (matched to HB/APAP); Drug: HB/APAP; Drug: Placebo (matched to VX-548)

• Study Type: Interventional
• Enrollment (Actual): 1075
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Medical Information; Phone Number: 617-341-6777; Email: medicalinfo@vrtx.com

Study Locations

• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Shoals Medical Trials Inc.
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
    • Bakersfield, California, United States, 93301
      • Trovare Clinical Research
    • San Diego, California, United States, 92103
      • Pacific Research Network Inc
    • Tarzana, California, United States, 91356
      • New Hope Research Development
    • West Covina, California, United States, 91790
      • New Hope Research Development
  • Florida
    • Hialeah, Florida, United States, 33014
      • Clinical Pharmacology of Miami
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Kansas Spine and Specialty Hospital
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Oklahoma
    • Jenks, Oklahoma, United States, 74037
      • Center for Orthopaedic Reconstruction and Excellence
  • Texas
    • Bellaire, Texas, United States, 77401
      • HD Research LLC | First Surgical Hospital
    • Carrollton, Texas, United States, 75006
      • HD Research LLC | Legent Orthopedic Hospital
    • Houston, Texas, United States, 77008
      • HD Research LLC | Houston Heights Hospital
    • McAllen, Texas, United States, 78501
      • Futuro Clinical Trials
    • San Antonio, Texas, United States, 78240
      • Endeavor Clinical Trials
    • Webster, Texas, United States, 77598
      • Houston Physicians Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VX-548; Participants will be randomized to receive VX-548.	Drug: VX-548; Tablets for oral administration.; Other Names: Suzetrigine; Drug: Placebo (matched to HB/APAP); Placebo matched to HB/APAP for oral administration.
Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP); Participants will be randomized to receive HB/APAP.	Drug: HB/APAP; Capsules for oral administration.; Drug: Placebo (matched to VX-548); Placebo matched to VX-548 for oral administration.
Placebo Comparator: Placebo; Participants will be randomized to receive placebo matched to VX-548 and HB/APAP.	Drug: Placebo (matched to HB/APAP); Placebo matched to HB/APAP for oral administration.; Drug: Placebo (matched to VX-548); Placebo matched to VX-548 for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) Compared to Placebo	Baseline to 48 Hours

Secondary Outcome Measures

Outcome Measure	Time Frame
SPID48 Compared to HB/APAP	Baseline to 48 Hours
Time to Greater than or Equal to (≥)2-Point Reduction in NPRS from Baseline Compared to Placebo	Baseline to 48 Hours
Time to ≥1-Point Reduction in NPRS from Baseline Compared to Placebo	Baseline to 48 Hours
Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo	At 48 Hours
Incidence of Vomiting or Nausea Compared to HB/APAP	Baseline to Day 17
Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo	Baseline to 24 hours
Time to First Use of Rescue Medication Compared to Placebo	Baseline to 48 hours
Proportion of Participants using Rescue Medication Compared to Placebo	Baseline to 48 hours
Total Rescue Medication Usage Compared to Placebo	Baseline to 48 hours
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline to Day 17

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: VX22-548-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No