drugset / Trial / NCT05553366

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

NCT05553366 ↗

Phase 3 Completed 1075 enrolled Vertex Pharmaceuticals Incorporated
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

EvaluationDrugModalityDoseRoute
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.