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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05661734
Recruitment Status : Completed
First Posted : December 22, 2022
Last Update Posted : March 20, 2024
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

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

Condition or disease Intervention/treatment Phase
Pain Drug: VX-548 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Single-arm Study Evaluating the Safety and Effectiveness of VX-548 for Acute Pain
Actual Study Start Date : January 9, 2023
Actual Primary Completion Date : December 12, 2023
Actual Study Completion Date : December 12, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: VX-548
Participants will receive VX-548 every 12 hours (q12h) up to 14 days.
 Drug: VX-548
Tablets for oral administration.
Other Name: Suzetrigine


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Day 28 ]

Secondary Outcome Measures :
  1. Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) [ Time Frame: Day 2 up to Day 14 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2)
  • Non-surgical participants with pain of new origin (not related to a prior known condition) 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 severe on the VRS and ≥4 on the NPRS

Key Exclusion Criteria:

  • Surgical participants:

    • History of previous surgery due to the same condition, except for procedures for 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 that resulted in any perioperative complications or that, in the opinion of the investigator or medical monitor, would preclude participation in the study
  • History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant

Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05661734


Locations
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United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Trovare Clinical Research | Bakersfield, CA
Bakersfield, California, United States, 93301
United States, Florida
Mart Medical Research Group LLC
Miami, Florida, United States, 33166
Mart Medical Research Group LLC
South Miami, Florida, United States, 33143
United States, Georgia
Atlanta Center for Medical Research | Atlanta, GA
Atlanta, Georgia, United States, 30331
United States, Kansas
Cypress Surgery Center
Wichita, Kansas, United States, 67226
United States, Nebraska
OrthoNebraska Hospital
Omaha, Nebraska, United States, 68144
United States, Oklahoma
Center for Orthopaedic Reconstruction and Excellence
Jenks, Oklahoma, United States, 74037
United States, Texas
HD Research LLC | First Surgical Hospital
Bellaire, Texas, United States, 77401
HD Research LLC | Legent Orthopedic Hospital
Carrollton, Texas, United States, 75006
Renovatio Clinical
Houston, Texas, United States, 77380
Futuro Clinical Trials
McAllen, Texas, United States, 78501
South Texas Spine & Surgical Hospital
San Antonio, Texas, United States, 78258
United States, Utah
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
More Information
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT05661734    
Other Study ID Numbers: VX22-548-107
First Posted: December 22, 2022    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations