Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
NCT ID: NCT05553366
Last Updated: 2025-08-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1075 participants
INTERVENTIONAL
2022-10-03
2023-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
NCT04977336
A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
NCT03206749
A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
NCT06619847
Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy
NCT04430088
A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
NCT03764072
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
Hydrocodone bitartrate/acetaminophen (HB/APAP)
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.
HB/APAP
Capsules for oral administration.
Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 2 days.
SUZ
Tablets for oral administration.
Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SUZ
Tablets for oral administration.
HB/APAP
Capsules for oral administration.
Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants 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
Exclusion Criteria
* Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot
* History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
* Any prior surgery within 1 month before the first study drug dose
* After Surgery
* Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
* Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shoals Medical Trials Inc.
Sheffield, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Anaheim Clinical Trials
Anaheim, California, United States
Trovare Clinical Research
Bakersfield, California, United States
Pacific Research Network Inc
San Diego, California, United States
New Hope Research Development
Tarzana, California, United States
New Hope Research Development
West Covina, California, United States
Clinical Pharmacology of Miami
Hialeah, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Kansas Spine and Specialty Hospital
Wichita, Kansas, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Center for Orthopaedic Reconstruction and Excellence
Jenks, Oklahoma, United States
HD Research LLC | First Surgical Hospital
Bellaire, Texas, United States
HD Research LLC | Legent Orthopedic Hospital
Carrollton, Texas, United States
HD Research LLC | Houston Heights Hospital
Houston, Texas, United States
Futuro Clinical Trials
McAllen, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Houston Physicians Hospital
Webster, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VX22-548-104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.