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

NCT04977336 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2025-06-25

Study results available
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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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2022-02-17
Completion
2022-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04977336 on ClinicalTrials.gov