A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain
NCT ID: NCT05661734
Last Updated: 2025-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
258 participants
INTERVENTIONAL
2023-01-09
2023-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Suzetrigine (SUZ)
Participants received SUZ 100 milligram (mg) as first dose, followed by SUZ 50 mg every 12 hours (q12h) for 14 days or until pain resolves, whichever occurs first.
Suzetrigine
Tablets for oral administration.
Interventions
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Suzetrigine
Tablets for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Anaheim Clinical Trials
Anaheim, California, United States
Trovare Clinical Research | Bakersfield, CA
Bakersfield, California, United States
Mart Medical Research Group LLC
Miami, Florida, United States
Mart Medical Research Group LLC
South Miami, Florida, United States
Atlanta Center for Medical Research | Atlanta, GA
Atlanta, Georgia, United States
Cypress Surgery Center
Wichita, Kansas, United States
OrthoNebraska Hospital
Omaha, Nebraska, United States
Center for Orthopaedic Reconstruction and Excellence
Jenks, Oklahoma, United States
HD Research LLC | First Surgical Hospital
Bellaire, Texas, United States
HD Research LLC | Legent Orthopedic Hospital
Carrollton, Texas, United States
Renovatio Clinical
Houston, Texas, United States
Futuro Clinical Trials
McAllen, Texas, United States
South Texas Spine & Surgical Hospital
San Antonio, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Countries
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References
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McCoun J, Winkle P, Solanki D, Urban J, Bertoch T, Oswald J, Swisher MW, Taber LA, Healey T, Jazic I, Correll DJ, Negulescu PA, Bozic C, Weiner SG; VX-548-107 Study Team. Suzetrigine, a Non-Opioid NaV1.8 Inhibitor With Broad Applicability for Moderate-to-Severe Acute Pain: A Phase 3 Single-Arm Study for Surgical or Non-Surgical Acute Pain. J Pain Res. 2025 Mar 25;18:1569-1576. doi: 10.2147/JPR.S509144. eCollection 2025.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VX22-548-107
Identifier Type: -
Identifier Source: org_study_id
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