Suzetrigine for Postoperative Pain

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Diego

Must not be taking: Opioids, Tramadol, CYP3A inhibitors, others

Disqualifiers: Opioid misuse, Renal impairment, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a single-center clinical study to investigate the efficacy of a Food and Drug Administration-approved analgesic, suzetrigine, to treat pain following non-mastectomy breast surgery in concert with a single-injection paravertebral nerve block.

Who Is on the Research Team?

Brian M Ilfeld, MD, MS

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

Inclusion Criteria

I am having breast surgery that is expected to cause moderate or more pain.

I am at least 18 years old.

I am scheduled to have a single injection nerve block.

Exclusion Criteria

History of opioid misuse or dependence

I have used opioids or tramadol daily for more than 4 weeks recently.

I have nerve or brain problems in the area where surgery is planned.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

Participants receive the first dose of suzetrigine and undergo standard preoperative procedures including paravertebral nerve block

1 day

1 visit (in-person)

Postoperative Treatment

Participants take suzetrigine tablets every 12 hours through the evening of postoperative day 2, with pain management and monitoring

3 days

Daily telephone calls

Follow-up

Participants are monitored for pain and opioid consumption, with data collection via telephone calls

7 days

Daily telephone calls

Long-term Follow-up

Participants are assessed for chronic pain and other outcomes at 6 months post-surgery

6 months

1 telephone call

What Are the Treatments Tested in This Trial?

Interventions

• Suzetrigine

How Is the Trial Designed?

Group I: Experimental: Suzetrigine Experimental Treatment 1 Intervention

Preoperatively, participants will be administered suzetrigine 100 mg orally. Postoperative study medication will consist of 5 tablets of suzetrigine 50 mg. Participants will be instructed to take 1 tablet every 12 hours following the initial dose through the evening of postoperative day 2.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Vertex Pharmaceuticals Incorporated

Industry 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