Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy (NCT05553366) | Clinical Trial Compass
CompletedPhase 3
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
United States1,075 participantsStarted 2022-10-03
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to Placebo
Timeframe: 0 to 48 hours After First Dose of Study Drug