A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

Last updated: May 12, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

2

Condition

Pain

Acute Pain

Treatment

Placebo (matched to HB/APAP)

Placebo (matched to VX-993)

HB/APAP

Clinical Study ID

NCT06619847
VX24-993-101
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

Before Surgery:

  • Participant scheduled to undergo a primary unilateral bunionectomy with distal firstmetatarsal osteotomy (i.e., Austin procedure) and internal fixation under regionalanesthesia (Mayo block)

After Surgery:

  • Participant is lucid and able to follow commands

  • All analgesic guidelines were followed during and after the bunionectomy

Exclusion

Key Exclusion Criteria:

Before Surgery:

  • Prior history of bunionectomy or other foot surgery on the index foot

  • History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within thelast 2 years

  • A known or clinically suspected active infection with human immunodeficiency virusor hepatitis B or C viruses

After Surgery:

  • Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitantsurgery such as hammertoe repair, or had medical complications during thebunionectomy

Other protocol defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 355
Treatment Group(s): 4
Primary Treatment: Placebo (matched to HB/APAP)
Phase: 2
Study Start date:
October 29, 2024
Estimated Completion Date:
October 16, 2025

Connect with a study center

  • Shoals Medical Trials Inc.

    Sheffield, Alabama 35660
    United States

    Active - Recruiting

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Completed

  • Woodland International Research Group

    Little Rock, Arkansas 72211
    United States

    Completed

  • Trovare Clinical Research

    Bakersfield, California 93301
    United States

    Active - Recruiting

  • New Hope Research Development | Tarzana, CA

    Tarzana, California 91356
    United States

    Completed

  • Clinical Pharmacology of Miami

    Miami, Florida 33014
    United States

    Completed

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Completed

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Completed

  • BioBehavioral Research of Austin

    Austin, Texas 78759
    United States

    Completed

  • HD Research LLC | First Surgical Hospital

    Bellaire, Texas 77401
    United States

    Completed

  • HD Research LLC | Legent Orthopedic Hospital

    Carrollton, Texas 75006
    United States

    Completed

  • Memorial Hermann Village

    Houston, Texas 77043
    United States

    Completed

  • Endeavor Clinical Trials

    San Antonio, Texas 78240
    United States

    Completed

  • JBR Clinical Research

    Salt Lake City, Utah 84107
    United States

    Completed

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