NCT04977336

A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after a bunionectomy.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	VX-548	Tablets for oral administration.
DRUG	HB/APAP	Capsules for oral administration.
DRUG	Placebo (matched to VX-548)	Placebo matched to VX-548 for oral administration.
DRUG	Placebo (matched to HB/APAP)	Placebo matched to HB/APAP for oral administration.

Timeline

• Start date: 2021-07-19
• Primary completion: 2022-02-17
• Completion: 2022-03-04
• First posted: 2021-07-26
• Last updated: 2025-06-25
• Results posted: 2025-06-25

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study