Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty

28. mai 2026 oppdatert av: Ajay Premkumar, Emory University
This study is a prospective, single-arm interventional trial enrolling patients undergoing total knee arthroplasty (TKA) for knee arthritis. All participants will receive Suzetrigine (brand name Journavx by Vertex Pharma) as part of a standardized multimodal perioperative analgesic regimen in addition to standard of care.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The objective of the study is to determine the effect suzetrigine has on postoperative pain, opioid use, sleep quality, and patient satisfaction when it is used as part of a multimodal pain regimen prescribed to patients after total knee arthroplasty.

The study will enroll eligible participants who are scheduled to receive a total knee arthroplasty. Participants will first consent to participate in the research study. They will then be asked to complete certain baseline measurements and instructed to begin wearing a device on their wrist that will quantify their activity and sleep quality ("sleep tracker"). They will complete a baseline KOOS JR survey. There are no additional surveys or diaries to complete pre-operatively. They will receive a suzetrigine prescription (the intervention) on the day of their total knee arthroplasty after the procedure has been completed in addition to the standard of care pain control regimen after surgery. They will complete a diary for a set time after surgery, and subject will continue to wear the sleep tracker for up to 2 weeks post-surgery. They will complete a daily sleep diary for 14 days after surgery to document sleep duration, sleep quality, nighttime awakenings, and other related factors. They will also complete a diary for 14 days after surgery that asks them to report their pain level 3 times daily, their nausea level 3 times daily, and the number of narcotic pills taken daily, and continue to wear their activity and sleep tracker. They will be asked to complete a pill tracking chart to confirm they are taking Journavx as directed for 14 days after surgery. 1 week and 2 weeks after surgery, they will complete a survey that quantifies their sleep related impairment. Approximately 3 months after surgery, subjects will complete another survey. Participants will have interactions with the study team until approximately 3 months after surgery.

Studietype

Intervensjonell

Registrering (Antatt)

75

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory Clinic
      • Atlanta, Georgia, Forente stater, 30329
        • Emory Clinic at Executive Park
      • Atlanta, Georgia, Forente stater, 30329
        • Emory Orthopaedics and Spine Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
  • Patients between the ages of 18 and 95 years.

Exclusion Criteria:

  • Patients with concurrent and significant injuries to other bones or organs.
  • Patients with local infections.
  • Minors unable to provide informed consent for participation in the study.
  • Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
  • Patients with pre-existing immune suppression, where further immune suppression with GCs could warrant unwarranted or unneeded risk.
  • Patients with preoperative opioid use, defined as daily use less than 4 weeks before the index surgery.
  • Patients with a history of severe heart disease (NYHA2), renal failure, or liver dysfunction
  • Patients with active peptic ulcer disease.
  • Patients neurological or psychiatric diseases, potentially influencing pain perception
  • Patients who are pregnant.
  • Patients with a history of alcohol or medical abuse, allergies to glucocorticoids, current daily use of glucocorticoids.
  • Patients who are unable to take NSAIDs.
  • Patients who receive Deep Venous Thrombosis (DVT) prophylaxis different than Aspirin (81mg) twice daily (BID).
  • Patients who have known diabetes mellitus as defined with an A1C greater than 6.5%.
  • Patients currently taking CYP3A inhibitors

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Suzetrigine Regimen Arm

Suzetrigine (JOURNAVX®) administered orally consisting of a course that lasts up to a maximum of 14 days.

The starting dose will be 100 mg orally taken as two 50 mg tablets on an empty stomach (at least 1 hour before or 2 hours after food). Maintenance dosing will begin 12 hours after the initial dose, at which point patients will take 50 mg orally every 12 hours.
Legemiddel: Suzetrigine
Suzetrigine is an orally administered, selective NaV1.8 voltage-gated sodium channel inhibitor being investigated as a non-opioid analgesic for the treatment of pain through inhibition of pain signal transmission in peripheral sensory neurons.
Andre navn:
  • JOURNAVX®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean pain intensity score on the Numeric Rating Scale (NRS)
Tidsramme: Day 0-14 postoperative
Pain will be measured using a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, using a Visual Analog Pain Scale (VAS-pain). Higher score correlates with worse outcome.
Day 0-14 postoperative
Average daily opioid consumption
Tidsramme: Day 0-14 postoperative
Postoperative opioid consumption will be quantified in morphine milligram equivalents (MME) during postoperative days 0-14.
Day 0-14 postoperative
Cumulative opioid consumption
Tidsramme: 3 weeks and 3 months postoperative
Postoperative opioid consumption will be quantified as cumulative MME at 3 weeks and 3 months.
3 weeks and 3 months postoperative

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Nausea scores postoperative
Tidsramme: Day 0-14 post-operative
A nausea assessment will be assessed using the Visual Analog Nausea Scale (VAS-nausea), which is ranked from 0 (no nausea) to 10 (highest amount of nausea). Patients will be asked to fill out the VAS-nausea each day until post-operative day 14.
Day 0-14 post-operative
Total sleep time
Tidsramme: Day 0-14 post-operative
Total sleep time will be collected using actigraphy during postoperative days 0-14.
Day 0-14 post-operative
Sleep efficiency
Tidsramme: Day 0-14 post-operative
Sleep efficiency will be measured by recording the ratio of time asleep to time in bed, using actigraphy during postoperative days 0-14.
Day 0-14 post-operative
Sleep latency
Tidsramme: Day 0-14 post-operative
Sleep latency will be measured by recording the time from "lights out" to sleep onset, using actigraphy during postoperative days 0-14.
Day 0-14 post-operative
Wake after sleep onset (WASO)
Tidsramme: Day 0-14 post-operative
Wake after sleep onset (WASO) will be assessed using actigraphy during postoperative days 0-14.
Day 0-14 post-operative
EQ5D Score
Tidsramme: 3 months post-operative
Health-related quality of life measure using the EQ-5D questionnaire, which assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a summary index score, where 1 represents full health and 0 represents death (higher values indicating better health status).
3 months post-operative
KOOS Jr Score
Tidsramme: Baseline, 3 months post-operative
Patient-reported knee function assessed using the Knee Injury and Osteoarthritis Outcome Score Junior (KOOS Jr). The KOOS Jr is a validated short-form instrument derived from the full KOOS, designed to evaluate knee health based on key items related to pain, symptoms, and physical function. Scores are transformed to a 0 to 100 scale, with higher scores indicating better knee function and fewer symptoms.
Baseline, 3 months post-operative

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Emory University

Samarbeidspartnere

Vertex Pharmaceuticals Incorporated

Etterforskere

  • Hovedetterforsker: Ajay Premkumar, MD, Emory University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. august 2028

Studiet fullført (Antatt)

1. august 2028

Datoer for studieregistrering

Først innsendt

28. mai 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026P000242

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere