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A Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Selected Surgeries

Phase 4
Recruiting
Conditions
Acute Pain
Interventions
Registration Number
NCT06887959
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Brief Summary

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of SUZ for acute pain after laparoscopic procedures of the intraperitoneal or retroperitoneal cavities or arthroscopic orthopedic procedures.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
200
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Suzetrigine (SUZ)SuzetrigineParticipants will receive SUZ for 14 days or until their pain resolves, whichever occurs first.
Primary Outcome Measures
NameTimeMethod
Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) for Pain Control at the End of TreatmentFrom Day 3 up to Day 14
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

Eximia Research-Durham

🇺🇸

Durham, North Carolina, United States

Scottsdale Clinical Trials

🇺🇸

Scottsdale, Arizona, United States

Woodland International Research Group

🇺🇸

Little Rock, Arkansas, United States

MedStar

🇺🇸

Baltimore, Maryland, United States

Oasis Clinical Research

🇺🇸

Las Vegas, Nevada, United States

OrthoCarolina - Hip & Knee Center

🇺🇸

Charlotte, North Carolina, United States

West Clinical Research

🇺🇸

Morehead City, North Carolina, United States

Seaside Clinical Research Institute

🇺🇸

Wilmington, North Carolina, United States

HD Research LLC | First Surgical Hospital

🇺🇸

Bellaire, Texas, United States

Memorial Hermann Village

🇺🇸

Houston, Texas, United States

Tidewater Clinical Research

🇺🇸

Norfolk, Virginia, United States

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