A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy (NCT04977336) | Clinical Trial Compass
CompletedPhase 2
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
United States274 participantsStarted 2021-07-19
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after a bunionectomy.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
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 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 other foot surgery on the index foot
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
* Any prior surgery within 1 month before the first study drug
* 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 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 Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug
Timeframe: 0 to 48 hours After First Dose of Study Drug