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A Single-Arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Aesthetic or Reconstructive Surgeries

Phase 4
Recruiting
Conditions
Acute Pain
Interventions
Registration Number
NCT06887972
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Brief Summary

The purpose of this study to evaluate the effectiveness, safety, and tolerability of SUZ as part of multimodal therapy (MMT) in treating acute postoperative pain.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
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)
  • Participants scheduled to undergo an aesthetic or reconstructive surgical procedure that would typically be treated with opioid therapy for at least 72 hours postoperatively

Key

Exclusion Criteria

• Participated in a previous study with SUZ or received Journavx

Other protocol defined Inclusion/Exclusion criteria may 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 (4)

Atlanta Center for Medical Research

🇺🇸

Atlanta, Georgia, United States

HD Research LLC | First Surgical Hospital

🇺🇸

Bellaire, Texas, United States

Memorial Hermann Village

🇺🇸

Houston, Texas, United States

JBR Clinical Research

🇺🇸

Salt Lake City, Utah, United States

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