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

NCT ID: NCT06887972

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-21

Study Completion Date

2025-11-06

Brief Summary

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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

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Conditions

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Acute Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Suzetrigine (SUZ)

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

Group Type EXPERIMENTAL

Suzetrigine

Intervention Type DRUG

Tablets for oral administration.

Interventions

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Suzetrigine

Tablets for oral administration.

Intervention Type DRUG

Other Intervention Names

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VX-548 SUZ JOURNAVX

Eligibility Criteria

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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

Exclusion Criteria

• Participated in a previous study with SUZ or received Journavx
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

Beth Israel Deaconess Medical Center - Surgery

Boston, Massachusetts, United States

Site Status

HD Research LLC | First Surgical Hospital

Bellaire, Texas, United States

Site Status

Memorial Hermann Village

Houston, Texas, United States

Site Status

JBR Clinical Research

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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VX24-548-113

Identifier Type: -

Identifier Source: org_study_id