A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
NCT ID: NCT06619847
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
367 participants
INTERVENTIONAL
2024-10-29
2025-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VX-993
Participants will be randomized to receive different dose levels of VX-993.
VX-993
Tablets for oral administration.
Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
Hydrocodone bitartrate/acetaminophen (HB/APAP)
Participants will be randomized to receive HB/APAP.
HB/APAP
Capsules for oral administration.
Placebo (matched to VX-993)
Placebo matched to VX-993 for oral administration.
Placebo
Participants will be randomized to receive placebo matched to VX-993 and HB/APAP.
Placebo (matched to VX-993)
Placebo matched to VX-993 for oral administration.
Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
Interventions
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VX-993
Tablets for oral administration.
HB/APAP
Capsules for oral administration.
Placebo (matched to VX-993)
Placebo matched to VX-993 for oral administration.
Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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VX24-993-101
Identifier Type: -
Identifier Source: org_study_id
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