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Recruiting
Phase 3
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

The purpose of this study is to evaluate the efficacy and safety of VX-548 for acute pain after a bunionectomy.

ClinicalTrials.gov Identifier
NCT05553366
Eligibility criteria
Sex
Age
18 Years - 80 Years
Phase
3
Key inclusion criteria
  • Before Surgery
  • Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)
  • After Surgery
  • Participant is lucid and able to follow commands
  • All analgesic guidelines were followed during and after the bunionectomy
Key exclusion criteria
  • Before Surgery
  • Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot
  • History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
  • Any prior surgery within 1 month before the first study drug dose
  • After Surgery
  • Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
  • Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization
Other protocol defined Inclusion/Exclusion criteria may apply.
Trial details
Condition
Acute Pain
Study duration
October 2022 - March 2024
Study type
Interventional
Intervention/Treatment
Drug : VX-548, Drug : HB/APAP, Drug : Placebo (matched to VX-548), Drug : Placebo (matched to HB/APAP)
Estimated enrollment
1000

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