A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain

Part of paid clinical trials in Anaheim, California.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT05661734
Phase
PHASE3
Status
Completed

Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Suzetrigine — DRUG
    Tablets for oral administration.

Study Details

The purpose of this study is to evaluate the safety and effectiveness of VX-548 in treating acute pain.

Key Dates

First listed
Dec 22, 2022
Start date
Jan 9, 2023
Status verified
Jun 2025
Primary completion
Dec 12, 2023
Completion
Dec 12, 2023

Study Design

Enrollment
258 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Suzetrigine (SUZ)
    Participants received SUZ 100 milligram (mg) as first dose, followed by SUZ 50 mg every 12 hours (q12h) for 14 days or until pain resolves, whichever occurs first.

Primary Outcome Measure

Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Day 30 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Anaheim Clinical TrialsAnaheimCalifornia92801-
Trovare Clinical Research | Bakersfield, CABakersfieldCalifornia93301-
Mart Medical Research Group LLCMiamiFlorida33166-
Mart Medical Research Group LLCSouth MiamiFlorida33143-
Atlanta Center for Medical Research | Atlanta, GAAtlantaGeorgia30331-
Cypress Surgery CenterWichitaKansas67226-
OrthoNebraska HospitalOmahaNebraska68144-
Center for Orthopaedic Reconstruction and ExcellenceJenksOklahoma74037-
HD Research LLC | First Surgical HospitalBellaireTexas77401-
HD Research LLC | Legent Orthopedic HospitalCarrolltonTexas75006-
Renovatio ClinicalHoustonTexas77380-
Futuro Clinical TrialsMcAllenTexas78501-
South Texas Spine & Surgical HospitalSan AntonioTexas78258-
Wasatch Clinical ResearchSalt Lake CityUtah84107-

Find similar trials in Anaheim, CA

By research site
Anaheim Clinical Trials· Anaheim, CATrovare Clinical Research | Bakersfield, CA· Bakersfield, CAMart Medical Research Group LLC· Miami, FLMart Medical Research Group LLC· South Miami, FLAtlanta Center for Medical Research | Atlanta, GA· Atlanta, GACypress Surgery Center· Wichita, KS

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