A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Phase 2

Completed

Interventions: Drug: HB/APAP
Drug: VX-548
Drug: Placebo (matched to HB/APAP)
Drug: Placebo (matched to VX-548)

Brief 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 & Eligibility

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

Arm && Interventions

Group	Intervention	Description
VX-548	Placebo (matched to HB/APAP)	Participants will be randomized to receive different dose levels of VX-548.
Hydrocodone bitartrate/acetaminophen (HB/APAP)	HB/APAP	Participants will receive HB/APAP.
Hydrocodone bitartrate/acetaminophen (HB/APAP)	Placebo (matched to VX-548)	Participants will receive HB/APAP.
Placebo	Placebo (matched to VX-548)	Participants will receive placebos matched to VX-548 and HB/APAP.
Placebo	Placebo (matched to HB/APAP)	Participants will receive placebos matched to VX-548 and HB/APAP.
VX-548	VX-548	Participants will be randomized to receive different dose levels of VX-548.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Day 1 up to Day 18

Locations (12): Shoals Medical Trials Inc.
🇺🇸
Sheffield, Alabama, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Anaheim Clinical Trials
🇺🇸
Anaheim, California, United States
Lotus Clinical Research
🇺🇸
Pasadena, California, United States
New Hope Research Development
🇺🇸
Tarzana, California, United States
Chesapeake Research Group
🇺🇸
Pasadena, Maryland, United States
Atlanta Center for Medical Research
🇺🇸
Atlanta, Georgia, United States
Midwest Clinical Research Center
🇺🇸
Dayton, Ohio, United States
Legent Orthopedic Hospital
🇺🇸
Carrollton, Texas, United States
First Surgical Hospital
🇺🇸
Bellaire, Texas, United States
JBR Clinical Research
🇺🇸
Salt Lake City, Utah, United States
Endeavor Clinical Trials
🇺🇸
San Antonio, Texas, United States