Evaluation of Pain Treatment After Total Knee Arthroplasty

May 8, 2026 updated by: Vertex Pharmaceuticals Incorporated

A Phase 4, Double-blind, Sequential Cohort Study of Pain Treatment and Recovery After Total Knee Arthroplasty

The purpose of the study is to characterize opioid use after total knee arthroplasty (TKA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Legent Orthopedic and Spine Hospital
      • Houston, Texas, United States, 77043
        • Recruiting
        • Memorial Hermann Village Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 an elective primary unilateral TKA surgery

Key Exclusion Criteria:

- History of previous TKA surgery on incident side

Other protocol defined Inclusion/Exclusion criteria will apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suzetrigine (SUZ)
Participants will receive SUZ for 14 days.
Drug: Suzetrigine
Tablets for oral administration.
Other Names:
  • VX-548
  • JOURNAVX
Placebo Comparator: Placebo
Participants will receive placebo matched to SUZ for 14 days
Drug: Placebo
Placebo matched to SUZ for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants who Remain Opioid-Free
Time Frame: From Day 1 up to Day 14
From Day 1 up to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX25-548-118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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