A Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Selected Surgeries
- 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
-
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
-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
Group Intervention Description Suzetrigine (SUZ) Suzetrigine Participants will receive SUZ for 14 days or until their pain resolves, whichever occurs first.
- Primary Outcome Measures
Name Time Method Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) for Pain Control at the End of Treatment From Day 3 up to Day 14
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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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