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
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
Interested in this trial?
About clinical trials
Volunteers who participate in clinical trials help make new medicines a reality. Clinical trials are carefully designed research studies in humans that evaluate the safety and efficacy of an investigational medicine.
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.
Location
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Recruiting1Shoals Medical Trials Inc.Sheffield Alabama 35660 United States
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Recruiting1Anaheim Clinical TrialsAnaheim California 92801 United States
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Recruiting1Alliance Research Institute, LLCCanoga Park California 91304 United States
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Recruiting1New Hope Research DevelopmentTarzana California 91356 United States
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Recruiting1Atlanta Center for Medical Research | Atlanta, GAAtlanta Georgia 30331 United States
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Recruiting1Kansas Spine and Specialty HospitalWichita Kansas 67226 United States
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Recruiting1HD Research LLC | First Surgical HospitalBellaire Texas 77401 United States
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Recruiting1HD Research LLC | Houston Heights HospitalHouston Texas 77008 United States
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Recruiting1Endeavor Clinical TrialsSan Antonio Texas 78240 United States
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Recruiting1South Texas Spine & Surgical HospitalSan Antonio Texas 78258 United States
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Recruiting1JBR Clinical ResearchSalt Lake City Utah 84107 United States