60 Participants NeededMy employer runs this trial

Suzetrigine for Pain

Recruiting at 1 trial location
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Vertex Pharmaceuticals Incorporated
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand opioid use for pain relief after knee replacement surgery (total knee arthroplasty). The study will test a new treatment called Suzetrigine, a potential pain relief medication, by comparing it to a placebo (a pill with no active medicine) to determine if it reduces the need for opioids. Candidates may qualify if they are scheduled for knee replacement surgery and have not had this surgery on the same knee before. As a Phase 4 trial, Suzetrigine is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for Suzetrigine?

Research has shown that Suzetrigine is generally safe and well-tolerated. Studies have found it causes fewer common side effects, such as nausea and dizziness, compared to opioids. Suzetrigine tends to cause fewer negative effects than both a placebo and some common painkillers, like acetaminophen with hydrocodone. The FDA has approved this treatment for managing moderate to severe acute pain, indicating it has passed important safety checks. While no treatment is without risks, previous research has demonstrated Suzetrigine's strong safety record.12345

Why are researchers enthusiastic about this study treatment?

Suzetrigine is unique because it offers a novel approach to pain management by potentially targeting pain pathways differently than traditional treatments like NSAIDs or opioids. Researchers are excited about Suzetrigine because it may work faster, potentially showing effectiveness within just 14 days, which is quicker than many existing options. Its distinct mechanism of action could provide an alternative for patients who don't respond well to current medications, offering hope for more effective pain relief with possibly fewer side effects.

What evidence suggests that Suzetrigine might be an effective treatment for pain after total knee arthroplasty?

Research has shown that suzetrigine effectively manages pain. Studies have found it provides significant relief for short-term pain. In this trial, participants will receive either suzetrigine or a placebo for 14 days. Previous trials demonstrated that suzetrigine matched opioids in pain relief but caused fewer side effects, such as nausea and vomiting. It proved especially successful in easing post-surgical pain, showing high effectiveness and good tolerance. Most patients rated their pain relief as "good" to "excellent," making it a promising non-opioid option for pain management.13678

Are You a Good Fit for This Trial?

This trial is for adults with a BMI between 18 and 40 who are scheduled to have their first knee replacement surgery on one knee. People with certain health conditions or other reasons that could affect the study may not be able to join.

Inclusion Criteria

Body mass index (BMI) of ≥18.0 to ≤40.0 kilogram per meter square (kg/m^2)
I am scheduled for my first knee replacement on one knee.

Exclusion Criteria

I have had a knee replacement on the affected side.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SUZ or placebo for 14 days after total knee arthroplasty

2 weeks

Follow-up

Participants are monitored for opioid use and recovery after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

Trial Overview

The study compares Suzetrigine, a new pain medication, to a placebo (inactive treatment) in people after knee replacement surgery. The goal is to see how these treatments affect opioid use for pain control.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Suzetrigine (SUZ)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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

Citations

The effectiveness and value of suzetrigine for moderate ...

We evaluated the efficacy and safety of suzetrigine in adults with moderate to severe acute pain against 4 treatment modalities.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41481839/

Suzetrigine, a selective NaV1.8 inhibitor in acute and ...

Recent findings: Phase 3 trials have demonstrated that suzetrigine provides a statistically significant and clinically meaningful reduction in acute ...

Suzetrigine for Acute Pain:Effectiveness and Value

We heard that education for providers around the efficacy of multimodal pain management would improve clinical decision making and outcomes.

Clinical Efficacy and Safety Profile of Suzetrigine: A Novel Non ...

Suzetrigine demonstrated comparable effectiveness in treating moderate to severe acute pain, with no statistically significant differences, ...

Efficacy and Clinical Trials | JOURNAVX® (suzetrigine)

The primary endpoint in both trials was JOURNAVX superiority vs placebo on the time-weighted sum of the pain intensity difference (SPID) as recorded on the ...

Suzetrigine: A Novel, Peripherally Acting Analgesic

Suzetrigine was generally safe and well tolerated with a lower incidence of adverse events than placebo and the acetaminophen/hydrocodone ...

Suzetrigine for Acute Pain Control in Patients With Multiple ...

Suzetrigine has also been shown to have comparable analgesia to oral opioids with fewer side effects, such as nausea, vomiting, and need for rescue pain ...

Suzetrigine as a Novel Non-opioid Analgesic Drug in Pain ...

Suzetrigine may offer an effective and safe alternative to opioids in pain treatment. ... safety data are available. Drug-drug interactions.