VX-548 for Post-Bunionectomy Pain

Recruiting at 20 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 foot surgery, 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

1075 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

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 bunion surgery by blocking or reducing pain signals.

Eligibility Criteria

This trial is for people who are clear-headed and can follow instructions, scheduled to have a specific type of foot surgery (bunionectomy) under certain anesthesia. They must have followed pain management guidelines before and after surgery. Those with previous foot surgeries, recent heart rhythm problems needing treatment, or any surgery in the last month cannot join.

Inclusion Criteria

Before Surgery

I'm sorry, but the phrase "After Surgery" on its own does not provide enough context for me to accurately summarize the criterion. Can you please provide more details or clarify the specific criterion you'd like me to summarize?

Participant is lucid and able to follow commands

Exclusion Criteria

You have had surgery on the big toe or the foot next to it in the past.

You have had irregular heartbeats in the past 2 years that needed medication to control them.

Any prior surgery within 1 month before the first study drug dose

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VX-548

Trial Overview The study tests VX-548's effectiveness and safety in managing acute pain post-bunionectomy compared to HB/APAP (a known pain reliever) and placebos that look like each drug but contain no active ingredients.

Participant Groups

Group I: VX-548 Experimental Treatment 2 Interventions

Participants will be randomized to receive VX-548.

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

Participants will be randomized to receive HB/APAP.

Group III: Placebo Placebo Group 2 Interventions

Participants will be randomized to receive placebo 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