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

Recruiting at 11 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Must not be taking: Anti-arrhythmia treatments

Disqualifiers: Prior abdominoplasty, Cardiac dysrhythmias, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

1118 Participants Needed

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

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

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

Group I: VX-548 Experimental Treatment 2 Interventions

Participants will receive VX-548.

Group II: Hydrocodone bitartrate/acetaminophen (HB/APAP) Active Control 2 Interventions

Participants will receive HB/APAP.

Group III: Placebo Placebo Group 2 Interventions

Participants will receive placebos matched to VX-548 and HB/APAP.

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology