A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
- Conditions
- Acute Pain
- Interventions
- Registration Number
- NCT06619847
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 355
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 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 other foot surgery on the index foot
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years
- A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses
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
Other protocol defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VX-993 VX-993 Participants will be randomized to receive different dose levels of VX-993. VX-993 Placebo (matched to HB/APAP) Participants will be randomized to receive different dose levels of VX-993. Hydrocodone bitartrate/acetaminophen (HB/APAP) HB/APAP Participants will be randomized to receive HB/APAP. Hydrocodone bitartrate/acetaminophen (HB/APAP) Placebo (matched to VX-993) Participants will be randomized to receive HB/APAP. Placebo Placebo (matched to VX-993) Participants will be randomized to receive placebos matched to VX-993 and HB/APAP. Placebo Placebo (matched to HB/APAP) Participants will be randomized to receive placebos matched to VX-993 and HB/APAP.
- Primary Outcome Measures
Name Time Method Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) From 0 to 48 Hours After the First Dose of Study Drug
- Secondary Outcome Measures
Name Time Method Proportion of Participants With Greater Than or Equal To (>=) 30 Percent (%) Reduction in NPRS at 48 Hours At 48 Hours After the First Dose of Study Drug Proportion of Participants With >=50% Reduction in NPRS at 48 Hours At 48 Hours After the First Dose of Study Drug Proportion of Participants With >=70% Reduction in NPRS at 48 Hours At 48 Hours After the First Dose of Study Drug Maximum Observed Plasma Concentration (Cmax) of VX-993 and its Metabolite Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-993 and its Metabolite 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-993 and its Metabolite 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 19
Trial Locations
- Locations (14)
Shoals Medical Trials Inc.
🇺🇸Sheffield, Alabama, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
Trovare Clinical Research
🇺🇸Bakersfield, California, United States
New Hope Research Development | Tarzana, CA
🇺🇸Tarzana, California, United States
Clinical Pharmacology of Miami
🇺🇸Miami, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
BioBehavioral Research of Austin
🇺🇸Austin, Texas, United States
HD Research LLC | First Surgical Hospital
🇺🇸Bellaire, Texas, United States
HD Research LLC | Legent Orthopedic Hospital
🇺🇸Carrollton, Texas, United States
Memorial Hermann Village
🇺🇸Houston, Texas, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States