drugset / Trial / NCT05553366
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.
Timeline
- Start
- 2022-10-03
- Primary completion
- 2023-12-15
- Completion
- 2023-12-15
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Suzetrigine (SUZ); p = 0.0002; ANCOVA NCT05553366 ↗
release “Treatment with VX-548 following abdominoplasty or bunionectomy surgery resulted in a statistically significant improvement on the primary endpoint of the time-weighted sum of the pain” vrtx.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 325 mg | Oral |
| Comparator | Hydrocodone bitartrate | Unknown | 5 mg | Oral |
| Subject | Suzetrigine | Small molecule | 50 mg | Oral |
Indications
No indication recorded.