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

Phase 3

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Suzetrigine (SUZ)	Suzetrigine	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.
VX-548	VX-548	Participants will receive VX-548 every 12 hours (q12h) up to 14 days.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Day 1 up to Day 30

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale	Day 14 or at Pain Resolution, whichever occurs first	The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 5-point Likert scale as: (poor, fair, good, very good or excellent). Percentage of participants who reported good, very good or excellent on the PGA scale was reported.

Locations (13): Anaheim Clinical Trials
🇺🇸
Anaheim, California, United States
Trovare Clinical Research | Bakersfield, CA
🇺🇸
Bakersfield, California, 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
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Anaheim Clinical Trials
🇺🇸Anaheim, California, United States