A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy (NCT06619847) | Clinical Trial Compass
CompletedPhase 2
A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
United States367 participantsStarted 2024-10-29
Plain-language summary
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.
Who can participate
Age range18 Years – 75 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:
* Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo 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 other foot surgery on the index foot
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years
* A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses
After Surgery:
* Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy
Other protocol defined inclusion/exclusion criteria may apply.
What they're measuring
1
Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48)
Timeframe: From 0 to 48 Hours After the First Dose of Study Drug