NCT07538570

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
8mo left

Started Apr 2026

Shorter than P25 for phase_4 pain

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 22, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Proportion of Participants who Remain Opioid-Free

    From Day 1 up to Day 14

Study Arms (2)

Suzetrigine (SUZ)

EXPERIMENTAL

Participants will receive SUZ for 14 days.

Drug: Suzetrigine

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to SUZ for 14 days

Drug: Placebo

Interventions

SuzetrigineDRUG

Tablets for oral administration.

Also known as: VX-548, JOURNAVX
Suzetrigine (SUZ)
PlaceboDRUG

Placebo matched to SUZ for oral administration

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 an elective primary unilateral TKA surgery

You may not qualify if:

  • \- History of previous TKA surgery on incident side

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Medical Information

CONTACT

617-341-6777medicalinfo@vrtx.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

April 22, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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/