Phase
Condition
Pain
Acute Pain
Treatment
Placebo (matched to HB/APAP)
Placebo (matched to VX-993)
HB/APAP
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Before Surgery:
- Participant scheduled to undergo a primary unilateral bunionectomy with distal firstmetatarsal osteotomy (i.e., Austin procedure) and internal fixation under regionalanesthesia (Mayo block)
After Surgery:
Participant is lucid and able to follow commands
All analgesic guidelines were followed during and after the bunionectomy
Exclusion
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) within thelast 2 years
A known or clinically suspected active infection with human immunodeficiency virusor hepatitis B or C viruses
After Surgery:
- Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitantsurgery such as hammertoe repair, or had medical complications during thebunionectomy
Other protocol defined inclusion/exclusion criteria may apply.
Study Design
Connect with a study center
Shoals Medical Trials Inc.
Sheffield, Alabama 35660
United StatesSite Not Available
Arizona Research Center
Phoenix, Arizona 85053
United StatesSite Not Available
Woodland International Research Group
Little Rock, Arkansas 72211
United StatesSite Not Available
Trovare Clinical Research
Bakersfield, California 93301
United StatesSite Not Available
New Hope Research Development | Tarzana, CA
Tarzana, California 91356
United StatesSite Not Available
Clinical Pharmacology of Miami
Miami, Florida 33172
United StatesSite Not Available
ForCare Clinical Research
Tampa, Florida 33613
United StatesSite Not Available
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesSite Not Available
BioBehavioral Research of Austin
Austin, Texas 78759
United StatesSite Not Available
HD Research LLC | First Surgical Hospital
Bellaire, Texas 77401
United StatesSite Not Available
HD Research LLC | Legent Orthopedic Hospital
Carrollton, Texas 75006
United StatesSite Not Available
Memorial Hermann Village
Houston, Texas 77043
United StatesSite Not Available
Endeavor Clinical Trials
San Antonio, Texas 78240
United StatesSite Not Available
JBR Clinical Research
Salt Lake City, Utah 84107
United StatesSite Not Available
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