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

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 4

Conditions: Acute Pain

Treatments: Drug: Suzetrigine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06887959

VX24-548-108

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Suzetrigine (SUZ)

Experimental group

Description:

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

Treatment:

Drug: Suzetrigine