Recruiting

Observational Study

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT07538570

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Suzetrigine

Placebo

Study Details

Brief summary:

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

Conditions

Pain

Study ID

NCT07538570

Start date

Apr 24, 2026

Status verified date

Aug, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Suzetrigine (SUZ)

Participants will receive SUZ for 14 days.

placebo comparator: Placebo

Participants will receive placebo matched to SUZ for 14 days

Interventions

Suzetrigine

Tablets for oral administration.

Placebo

Placebo matched to SUZ for oral administration

Primary outcome measure

  • Total Opioid Usage [ Time Frame: 24 hours to 168 hours after the first dose of study drug ]

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777medicalinfo@vrtx.com

Locations

Legent Orthopedic and Spine Hospital

Recruiting

Bellaire, Texas, United States, 77401

Memorial Hermann Village Office

Recruiting

Houston, Texas, United States, 77043

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-08-18.