Vertex-108 (Laparoscopic or Arthroscopic Surgeries) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an investigational drug called suzetrigine (the study drug) is a safe and effective option to help people who have acute postoperative pain.
What is the Condition Being Studied?
Laparoscopic or Arthroscopic Surgeries
Who Can Participate in the Study?
Adults ages 18+ who:
- Have a body mass index (BMI) between 18 and 40
- Are scheduled for certain laparoscopic or arthroscopic surgeries at Duke
- Are not allergic to opioid medications or non-steroidal anti-inflammatory drugs (NSAIDs)
- Have never taken suzetrigine previously
For more information, contact the study team at piper.boykin@duke.edu.
Grupo etario
Adultos
What is Involved?
Si elige unirse a este estudio, podrá:
- Start taking the study drug before your scheduled surgery and continue to take it for at least 14 days after your surgery or until your pain goes away (whichever comes first)
- Take acetaminophen and ibuprofen in addition to the study drug for up to 14 days after surgery or as long as pain continues
- Fill out surveys
- Return to our clinic for about 3 follow-up visits after your surgery
Study Details
Full Title
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
Principal Investigator
Especialista en anestesiología
Protocol Number
IRB:
PRO00117274
NCT:
NCT06887959
Phase
Phase
IV
ClinicalTrials.gov
View on ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción