Evaluation of Pain Treatment After Total Knee Arthroplasty

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07538570

Enrollment

Registered

2026-04-20

Start date

2026-04-24

Completion date

2027-01-30

Last updated

2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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

Interventions

DRUGSuzetrigine

Tablets for oral administration.

DRUGPlacebo

Placebo matched to SUZ for oral administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion 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 an elective primary unilateral TKA surgery Key

Exclusion criteria

\- History of previous TKA surgery on incident side Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame
Total Opioid Usage	24 hours to 168 hours after the first dose of study drug

Countries

United States

Contacts

CONTACTMedical Information

medicalinfo@vrtx.com617-341-6777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026