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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04977336
Other study ID # VX21-548-101
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 19, 2021
Est. completion date March 4, 2022

Study information

Verified date February 2023
Source Vertex Pharmaceuticals Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after a bunionectomy.


Recruitment information / eligibility

Status Completed
Enrollment 274
Est. completion date March 4, 2022
Est. primary completion date February 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key Inclusion Criteria: - Before Surgery: - Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block) - After Surgery: - Participant is lucid and able to follow commands - All analgesic guidelines were followed during and after the bunionectomy Key Exclusion Criteria: - Before Surgery: - Prior history of bunionectomy or other foot surgery on the index foot - History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) - Any prior surgery within 1 month before the first study drug - After Surgery: - Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization Other protocol defined inclusion/exclusion criteria may apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VX-548
Tablets for oral administration.
HB/APAP
Capsules for oral administration.
Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.

Locations

Country Name City State
United States Anaheim Clinical Trials Anaheim California
United States Atlanta Center for Medical Research Atlanta Georgia
United States First Surgical Hospital Bellaire Texas
United States Legent Orthopedic Hospital Carrollton Texas
United States Midwest Clinical Research Center Dayton Ohio
United States Chesapeake Research Group Pasadena Maryland
United States Lotus Clinical Research Pasadena California
United States Arizona Research Center Phoenix Arizona
United States JBR Clinical Research Salt Lake City Utah
United States Endeavor Clinical Trials San Antonio Texas
United States Shoals Medical Trials Inc. Sheffield Alabama
United States New Hope Research Development Tarzana California

Sponsors (1)

Lead Sponsor Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time-weighted sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug 0 to 48 Hours After the First Dose of Study Drug
Secondary Time-weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug 0 to 24 Hours After the First Dose of Study Drug
Secondary Proportions of Participants With >=30 Percent (%), >=50%, and >=70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug At 48 Hours After the First Dose of Study Drug
Secondary Maximum Observed Plasma Concentration (Cmax) of VX-548 Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Secondary Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548 Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Secondary Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Day 18
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