Recruiting
Phase 3
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

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

ClinicalTrials.gov Identifier
NCT05558410
Eligibility criteria
Sex
Age
18 Years - 80 Years
Phase
3
Key inclusion criteria
  • Before Surgery
  • Participant scheduled to undergo a standard ("full") abdominoplasty procedure
  • After Surgery
  • Participant is lucid and able to follow commands and able to swallow oral medications
  • All analgesic guidelines were followed during and after the abdominoplasty
  • Abdominoplasty procedure duration less than or equal to (≤3) hours
Key exclusion criteria
  • Before Surgery
  • Prior history of abdominoplasty
  • History of Intra-abdominal and/or pelvic surgery that resulted into complications
  • 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 non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty
  • Participant had a medical complication during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
Other protocol defined Inclusion/Exclusion criteria may apply.
Trial details
Condition
Acute Pain
Study duration
October 2022 - March 2024
Study type
Interventional
Intervention/Treatment
Drug : VX-548, Drug : HB/APAP, Drug : Placebo (matched to VX-548), Drug : Placebo (matched to HB/APAP)
Estimated enrollment
1000

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About clinical trials

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If you’re interested in participating in a Vertex clinical trial, we encourage you to speak with your health care provider first about what’s involved and your eligibility. 

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Location
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  • Recruiting
    1
    Shoals Medical Trials Inc.
    Sheffield Alabama 35660 United States
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    1
    Arizona Research Center
    Phoenix Arizona 85053 United States
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    1
    Woodland International Research Group
    Little Rock Arkansas 72211 United States
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    1
    Anaheim Clinical Trials
    Anaheim California 92801 United States
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    1
    Alliance Research Institute, LLC
    Canoga Park California 91304 United States
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    1
    New Hope Research Development
    Tarzana California 91356 United States
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    1
    Atlanta Center for Medical Research | Atlanta, GA
    Atlanta Georgia 30331 United States
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    1
    Kansas Spine and Specialty Hospital
    Wichita Kansas 67226 United States
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    1
    HD Research LLC | First Surgical Hospital
    Bellaire Texas 77401 United States
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    1
    HD Research LLC | Houston Heights Hospital
    Houston Texas 77008 United States
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    1
    Endeavor Clinical Trials
    San Antonio Texas 78240 United States
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    1
    South Texas Spine & Surgical Hospital
    San Antonio Texas 78258 United States
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    1
    JBR Clinical Research
    Salt Lake City Utah 84107 United States