100 Participants Needed

Suzetrigine for Acute Pain

Recruiting at 3 trial locations
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Vertex Pharmaceuticals Incorporated
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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. Please consult with the trial coordinators for more details.

How does the drug Suzetrigine differ from other treatments for acute pain?

Suzetrigine may be unique in its approach to treating acute pain by potentially combining mechanisms similar to those of suprofen, which inhibits prostaglandin biosynthesis, and lamotrigine, which has shown effectiveness in reducing pain through neuronal sensitization. This combination could offer a novel way to manage pain without the side effects associated with opioids or traditional non-steroidal anti-inflammatory drugs.12345

What is the purpose of this trial?

The purpose of this study to evaluate the effectiveness, safety, and tolerability of SUZ as part of multimodal therapy (MMT) in treating acute postoperative pain.

Eligibility Criteria

This trial is for individuals with a BMI of 18.0 to 40.0 kg/m^2 who are scheduled for aesthetic or reconstructive surgery, normally treated with opioids post-surgery. It's not specified who can't join the trial.

Inclusion Criteria

I am scheduled for surgery that usually requires opioids for pain management for at least 3 days afterwards.
My BMI is between 18.0 and 40.0.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Suzetrigine (SUZ) as part of multimodal therapy for up to 14 days or until pain resolves

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Suzetrigine
Trial Overview The study is testing Suzetrigine (SUZ) as part of a multimodal therapy approach to manage acute pain after certain surgeries, aiming to assess its effectiveness and safety.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Suzetrigine (SUZ)Experimental Treatment1 Intervention
Participants will receive SUZ for 14 days or until their pain resolves, whichever occurs first.

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

References

Effect of lamotrigine in the acute and chronic hyperalgesia induced by PGE2 and in the chronic hyperalgesia in rats with streptozotocin-induced diabetes. [2021]
Mechanism of action of suprofen, a new peripheral analgesic, as demonstrated by its effects on several nociceptive mediators. [2019]
Clinical effectiveness of lamotrigine and plasma levels in essential and symptomatic trigeminal neuralgia. [2022]
Suprofen: the pharmacology and clinical efficacy of a new non-narcotic peripheral analgesic. [2013]
Antinociception induced by SM 32 depends on a central cholinergic mechanism. [2019]
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