A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain

Last updated: December 9, 2024
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Completed

Phase

3

Condition

Acute Pain

Pain

Treatment

VX-548

Clinical Study ID

NCT05661734
VX22-548-107
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of VX-548 in treating acute pain.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than (<) 40.0kilogram per meter square (kg/m^2)

  • Non-surgical participants with pain of new origin (not related to a prior knowncondition) that is moderate or severe on the verbal categorical rating scale (VRS)and ≥4 on the numeric pain rating scale (NPRS)

  • Surgical participants reporting pain at the surgical site that is moderate or severeon the VRS and ≥4 on the NPRS

Exclusion

Key Exclusion Criteria:

  • Surgical participants:

  • History of previous surgery due to the same condition, except for proceduresfor which a previous surgery on the contra-lateral limb or organ is allowed

  • History of a prior surgical procedure in the same region of the body thatresulted in any perioperative complications or that, in the opinion of theinvestigator or medical monitor, would preclude participation in the study

  • History of any illness or any clinical condition that, in the opinion of theinvestigator, might confound the results of the study or pose an additional risk inadministering study drug to the participant

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 258
Treatment Group(s): 1
Primary Treatment: VX-548
Phase: 3
Study Start date:
January 09, 2023
Estimated Completion Date:
December 12, 2023

Connect with a study center

  • Research Center - Tucson Orthopeadic Institute

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Anaheim Clinical Trials

    Anaheim, California 92801
    United States

    Site Not Available

  • Trovare Clinical Research | Bakersfield, CA

    Bakersfield, California 93301
    United States

    Site Not Available

  • New Hope Research Development | Tarzana, CA

    Tarzana, California 91356
    United States

    Site Not Available

  • Mart Medical Research Group LLC

    Miami, Florida 33166
    United States

    Site Not Available

  • Mart Medical Research Group LLC

    South Miami, Florida 33143
    United States

    Site Not Available

  • Atlanta Center for Medical Research | Atlanta, GA

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Duly Health

    Westmont, Illinois 60559
    United States

    Site Not Available

  • Cypress Surgery Center

    Wichita, Kansas 67226
    United States

    Site Not Available

  • OrthoNebraska Hospital

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Center for Orthopaedic Reconstruction and Excellence

    Jenks, Oklahoma 74037
    United States

    Site Not Available

  • HD Research LLC | First Surgical Hospital

    Bellaire, Texas 77401
    United States

    Site Not Available

  • HD Research LLC | Legent Orthopedic Hospital

    Carrollton, Texas 75006
    United States

    Site Not Available

  • Renovatio Clinical

    Houston, Texas 77380
    United States

    Site Not Available

  • Futuro Clinical Trials

    McAllen, Texas 78501
    United States

    Site Not Available

  • South Texas Spine & Surgical Hospital

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Renovatio Clinical

    Woodland, Texas 77380
    United States

    Site Not Available

  • Wasatch Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

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