Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
- Conditions
- Acute Pain
- Interventions
- Registration Number
- NCT05553366
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 for acute pain after a bunionectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1075
-
Before Surgery
- Participants 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
-
Before Surgery
- Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot
- History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
- Any prior surgery within 1 month before the first study drug dose
-
After Surgery
- Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
- Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo (matched to VX-548) Participants will be randomized to receive placebo matched to VX-548 and HB/APAP. VX-548 VX-548 Participants will be randomized to receive VX-548. Hydrocodone bitartrate/acetaminophen (HB/APAP) Placebo (matched to VX-548) Participants will be randomized to receive HB/APAP. VX-548 Placebo (matched to HB/APAP) Participants will be randomized to receive VX-548. Hydrocodone bitartrate/acetaminophen (HB/APAP) HB/APAP Participants will be randomized to receive HB/APAP. Placebo Placebo (matched to HB/APAP) Participants will be randomized to receive placebo matched to VX-548 and HB/APAP.
- Primary Outcome Measures
Name Time Method Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) Compared to Placebo Baseline to 48 Hours
- Secondary Outcome Measures
Name Time Method SPID48 Compared to HB/APAP Baseline to 48 Hours Time to Greater than or Equal to (≥)2-Point Reduction in NPRS from Baseline Compared to Placebo Baseline to 48 Hours Time to First Use of Rescue Medication Compared to Placebo Baseline to 48 hours Proportion of Participants using Rescue Medication Compared to Placebo Baseline to 48 hours Time to ≥1-Point Reduction in NPRS from Baseline Compared to Placebo Baseline to 48 Hours Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo At 48 Hours Total Rescue Medication Usage Compared to Placebo Baseline to 48 hours Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline to Day 17 Incidence of Vomiting or Nausea Compared to HB/APAP Baseline to Day 17 Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo Baseline to 24 hours
Trial Locations
- Locations (20)
Kansas Spine and Specialty Hospital
🇺🇸Wichita, Kansas, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Futuro Clinical Trials
🇺🇸McAllen, Texas, United States
Houston Physicians Hospital
🇺🇸Webster, Texas, United States
Shoals Medical Trials Inc.
🇺🇸Sheffield, Alabama, United States
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
Trovare Clinical Research
🇺🇸Bakersfield, California, United States
New Hope Research Development
🇺🇸West Covina, California, United States
Clinical Pharmacology of Miami
🇺🇸Hialeah, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Center for Orthopaedic Reconstruction and Excellence
🇺🇸Jenks, Oklahoma, United States
HD Research LLC | First Surgical Hospital
🇺🇸Bellaire, Texas, United States
HD Research LLC | Legent Orthopedic Hospital
🇺🇸Carrollton, Texas, United States
HD Research LLC | Houston Heights Hospital
🇺🇸Houston, Texas, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
Pacific Research Network Inc
🇺🇸San Diego, California, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States