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VX-548 for Post-Bunionectomy Pain

Phase 3
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 48 hours
Awards & highlights

Study Summary

This trial will study if a new drug is safe & effective to reduce pain after a bunion surgery.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the side effects of VX-548 aren't specified here, typical side effects for acute pain medications may include nausea, dizziness, headache, stomach upset or bleeding risks. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Secondary outcome measures
Incidence of Vomiting or Nausea Compared to HB/APAP
Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo
Proportion of Participants using Rescue Medication Compared to Placebo
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: VX-548Experimental Treatment2 Interventions
Participants will be randomized to receive VX-548.
Group II: Hydrocodone bitartrate/acetaminophen (HB/APAP)Active Control2 Interventions
Participants will be randomized to receive HB/APAP.
Group III: PlaceboPlacebo Group2 Interventions
Participants will be randomized to receive placebo matched to VX-548 and HB/APAP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-548
2022
Completed Phase 3
~3500
Placebo (matched to HB/APAP)
2021
Completed Phase 3
~2770

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
31,312 Total Patients Enrolled
7 Trials studying Acute Pain
2,546 Patients Enrolled for Acute Pain

Media Library

VX-548 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05553366 — Phase 3
Acute Pain Research Study Groups: Hydrocodone bitartrate/acetaminophen (HB/APAP), VX-548, Placebo
Acute Pain Clinical Trial 2023: VX-548 Highlights & Side Effects. Trial Name: NCT05553366 — Phase 3
VX-548 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05553366 — Phase 3
Acute Pain Patient Testimony for trial: Trial Name: NCT05553366 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do elderly patients fit the age criteria for this experiment?

"Eligibility for this specific trial is reserved for patients aged 18 to 80. If you are not within this age bracket, there may be other clinical trials better suited for you as there 24 trials for minors and 126 for seniors."

Answered by AI

What is the VX-548's regulatory status?

"VX-548 has undergone Phase 3 clinical trials, signifying that there is both efficacy and safety data available."

Answered by AI

Are new participants currently being sought for this experiment?

"That is accurate, the online information hosted on clinicaltrials.gov states that this research is looking for 1000 people to enroll between 9 different locations. The study was first posted on October 3rd, 2020 and was updated October 18th, 2020."

Answered by AI

How can I become a subject in this clinical trial?

"To be eligible for this study, participants must be aged between 18 and 80 and experiencing acute pain. In addition, they should before surgery, after surgery, be lucid and able to follow commands, and be scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block). All analgesic guidelines were followed during and after the bunionectomy."

Answered by AI

How many people are agreeing to be a part of this research project?

"In order to gain statistically relevant data, this study requires the participation of 1000 individuals that meet the pre-specified inclusion criteria. These patients can be recruited from multiple locations, such as Shoals Medical Trials Inc. in Sheffield, Alabama and HD Research LLC | First Surgical Hospital in Bellaire, Florida."

Answered by AI

Can you give me a ballpark estimate of how many hospitals are testing this new treatment?

"At the moment, this clinical trial is looking for patients from 9 different sites. These locations include Sheffield, Bellaire and Tampa. If you are considering participating in this trial, look for the site that is most convenient for you to reduce travel."

Answered by AI

Who else is applying?

What state do they live in?
Arkansas
What site did they apply to?
HD Research LLC | Houston Heights Hospital
Anaheim Clinical Trials
Trovare Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I need a bunion surgery and I know they are painful.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Anaheim Clinical Trials: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
2022. "Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05553366.
~430 spots leftby Apr 2025
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