VX-993 for Acute Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a new drug, VX-993, in reducing acute pain after bunion surgery. Researchers aim to compare the efficacy and safety of VX-993 with a common pain reliever, hydrocodone/acetaminophen, and a placebo. Individuals scheduled for a specific type of bunion surgery, known as an Austin procedure, and who have not undergone foot surgery before, may qualify. Participants will receive either VX-993, the standard pain medication, or a placebo to determine which best manages pain. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that VX-993 is generally safe and well tolerated. In earlier studies, most side effects were mild to moderate, and no serious side effects were reported. While some individuals might experience minor discomfort, VX-993 has not caused any major health issues in the trials so far.12345
Why do researchers think this study treatment might be promising for acute pain?
Most treatments for acute pain, like hydrocodone bitartrate/acetaminophen (HB/APAP), work by blocking pain signals in your brain. But VX-993 is unique because it targets the pain at its source with a different mechanism, potentially offering pain relief without the side effects associated with opioids. Researchers are excited about VX-993 because it could provide a safer alternative to traditional painkillers, reducing the risk of addiction and other adverse effects.
What evidence suggests that VX-993 might be an effective treatment for acute pain?
This trial will compare VX-993, an investigational treatment, with hydrocodone bitartrate/acetaminophen (HB/APAP) and a placebo. Research has shown that VX-993 did not reduce sudden pain. In earlier studies, VX-993 was no more effective at managing pain than a placebo, which contains no active medicine. Although this treatment aimed to block pain signals, it did not surpass current options. Consequently, the development of VX-993 for treating sudden pain has been discontinued.12346
Are You a Good Fit for This Trial?
This trial is for individuals scheduled to have a bunionectomy (a type of foot surgery) using regional anesthesia. Participants must be able to follow instructions and adhere to pain management guidelines before and after the procedure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive randomized doses of VX-993, HB/APAP, or placebo to evaluate efficacy and safety for acute pain after bunionectomy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VX-993
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
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