1118 Participants Needed

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

Recruiting at 11 trial locations
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Vertex Pharmaceuticals Incorporated
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing VX-548, a new medication, to see if it can help reduce pain in patients who have had abdominoplasty surgery. VX-548 likely works by blocking pain signals in the body.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Eligibility Criteria

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
After Surgery: All analgesic guidelines were followed during and after the abdominoplasty
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Exclusion Criteria

Before Surgery: Prior history of abdominoplasty
After Surgery: Participant had a non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty
Before Surgery: History of Intra-abdominal and/or pelvic surgery that resulted into complications
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VX-548, HB/APAP, or placebo for acute pain management after abdominoplasty

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • HB/APAP
  • Placebo (matched to HB/APAP)
  • Placebo (matched to VX-548)
  • VX-548
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: VX-548Experimental Treatment2 Interventions
Participants will receive VX-548.
Group II: Hydrocodone bitartrate/acetaminophen (HB/APAP)Active Control2 Interventions
Participants will receive HB/APAP.
Group III: PlaceboPlacebo Group2 Interventions
Participants will receive placebos matched to VX-548 and HB/APAP.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials
267
Recruited
36,100+
Dr. David Altshuler profile image

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani profile image

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

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