A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
NCT ID: NCT04977336
Last Updated: 2025-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
274 participants
INTERVENTIONAL
2021-07-19
2022-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received placebo matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
HB/APAP
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.
HB/APAP
Capsules for oral administration.
VX-548: Low Dose
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg tablet every 12 hours (q12h) for 2 days.
VX-548
Tablets for oral administration.
VX-548: Mid Dose
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
VX-548
Tablets for oral administration.
VX-548: High Dose
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
VX-548
Tablets for oral administration.
Interventions
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VX-548
Tablets for oral administration.
HB/APAP
Capsules for oral administration.
Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant 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 other foot surgery on the index foot
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
* Any prior surgery within 1 month before the first study drug
* After Surgery:
* Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization
18 Years
75 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Shoals Medical Trials Inc.
Sheffield, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
Lotus Clinical Research
Pasadena, California, United States
New Hope Research Development
Tarzana, California, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Chesapeake Research Group
Pasadena, Maryland, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
First Surgical Hospital
Bellaire, Texas, United States
Legent Orthopedic Hospital
Carrollton, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Countries
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References
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Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.
Russo MA, Baron R, Dickenson AH, Kern KU, Santarelli DM. Ambroxol for neuropathic pain: hiding in plain sight? Pain. 2023 Jan 1;164(1):3-13. doi: 10.1097/j.pain.0000000000002693. Epub 2022 May 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VX21-548-101
Identifier Type: -
Identifier Source: org_study_id
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