Evaluating Suzetrigine for Acute Pain After Surgery

A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Laparoscopic Procedures of the Intraperitoneal or Retroperitoneal Cavities or Arthroscopic Orthopedic Procedures

This study is testing if a new pain medication called Suzetrigine can help people manage pain after surgery without using traditional opioids.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vertex Pharmaceuticals Incorporated (Industry-sponsored)
• Locations: 11 sites (Scottsdale, Arizona and 10 other locations)
• Trial ID: NCT06887959 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness, safety, and tolerability of Suzetrigine (SUZ) in managing acute pain following specific surgical procedures, including laparoscopic and arthroscopic surgeries. It is a single-arm, Phase 4 interventional trial where participants will receive SUZ for pain management instead of traditional opioid therapies. The study will focus on patients who are scheduled for surgeries that typically require opioid treatment for at least 72 hours post-operation. The outcomes will help determine if SUZ can provide a safer alternative for pain relief in these settings.

Who should consider this trial

Good fit: Ideal candidates are adults with a BMI between 18.0 and 40.0 who are scheduled for laparoscopic or arthroscopic surgeries that usually require opioid pain management.

Not a fit: Patients who have previously participated in studies involving Suzetrigine or received Journavx may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a non-opioid option for managing acute pain, potentially reducing reliance on opioids and their associated risks.

How similar studies have performed: While this approach is relatively novel, previous studies on non-opioid pain management have shown promise, indicating potential for success.

Eligibility criteria

Key Inclusion Criteria:

* Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than or equal to (≤) 40.0 kilogram per meter square (kg/m\^2)
* Scheduled to undergo a procedure that is in one of the following categories that would typically be treated with opioid therapy for at least 72 hours postoperatively such as

  * Laparoscopic intraperitoneal or retroperitoneal procedure
  * Arthroscopic orthopedic procedure

Key Exclusion Criteria:

-Participated in previous study with Suzetrigine or received Journavx

Other protocol defined Inclusion/Exclusion criteria will apply.

Where this trial is running

Scottsdale, Arizona and 10 other locations

• Scottsdale Clinical Trials — Scottsdale, Arizona, United States (Recruiting)
• Woodland International Research Group — Little Rock, Arkansas, United States (Recruiting)
• MedStar — Baltimore, Maryland, United States (Recruiting)
• Oasis Clinical Research — Las Vegas, Nevada, United States (Recruiting)
• OrthoCarolina - Hip & Knee Center — Charlotte, North Carolina, United States (Recruiting)
• Eximia Research-Durham — Durham, North Carolina, United States (Recruiting)
• West Clinical Research — Morehead City, North Carolina, United States (Recruiting)
• Seaside Clinical Research Institute — Wilmington, North Carolina, United States (Recruiting)
• HD Research LLC | First Surgical Hospital — Bellaire, Texas, United States (Recruiting)
• Memorial Hermann Village — Houston, Texas, United States (Recruiting)
• Tidewater Clinical Research — Norfolk, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Medical Information

Conditions Acute Pain