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

NCT06887959 | Completed Phase 4 FDA Drug

• 1 other identifier: VX24-548-108
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 17

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Suzetrigine (SUZ)

EXPERIMENTAL

Participants will receive SUZ for 14 days or until their pain resolves, whichever occurs first.

Drug: Suzetrigine

Interventions

Suzetrigine DRUG

Tablets for oral administration.

Also known as: VX-548, SUZ, Journavx

Suzetrigine (SUZ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participated in previous study with Suzetrigine or received Journavx

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (17)

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Gulfcoast Research Institute

Sarasota, Florida, 34232, United States

Location

MedStar

Baltimore, Maryland, 21218, United States

Location

Oasis Clinical Research

Las Vegas, Nevada, 89121, United States

Location

Cooper University HealthCare (CUH)

Camden, New Jersey, 08103, United States

Location

North Shore University Hospital - Anesthesiology

Manhasset, New York, 11030, United States

Location

OrthoCarolina - Hip & Knee Center

Charlotte, North Carolina, 28207, United States

Location

Eximia Research-Durham

Durham, North Carolina, 27704, United States

Location

Duke University Hospital - Anesthesiology

Durham, North Carolina, 27710, United States

Location

West Clinical Research

Morehead City, North Carolina, 28557, United States

Location

Seaside Clinical Research Institute

Wilmington, North Carolina, 28412, United States

Location

UH Cleveland Medical Center - Anesthesiology

Cleveland, Ohio, 44106, United States

Location

University of Tennessee Medical Center - Anethesiology

Knoxville, Tennessee, 37920, United States

Location

HD Research LLC | First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Memorial Hermann Village

Houston, Texas, 77043, United States

Location

Tidewater Clinical Research

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 21, 2025
• Study Start: March 27, 2025
• Primary Completion: October 27, 2025
• Study Completion: November 10, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)