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VX-993 for Acute Pain
Phase 2
Recruiting
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Participant is lucid and able to follow commands
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial aims to test how well VX-993 works in treating pain after a bunion surgery, while also checking for any side effects and how the body processes the medication.
Who is the study for?
This trial is for individuals scheduled to have a bunionectomy (a type of foot surgery) using regional anesthesia. Participants must be able to follow instructions and adhere to pain management guidelines before and after the procedure.
What is being tested?
The study tests VX-993's effectiveness in managing acute pain post-bunionectomy, comparing it with HB/APAP (likely a standard painkiller) and placebos that match each drug. It also assesses safety, tolerability, and how the body processes VX-993.
What are the potential side effects?
While specific side effects are not listed here, common ones may include nausea, drowsiness, dizziness from pain medications like HB/APAP or new drugs such as VX-993. Placebo groups should experience minimal side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a bunion surgery on one foot with a specific technique.
Select...
I am mentally alert and can follow instructions.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery on my foot before.
Select...
I have had heart rhythm problems treated in the last 2 years.
Select...
I do not have an active HIV, hepatitis B, or hepatitis C infection.
Select...
I had surgery for a severe foot deformity or complications during bunion surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: VX-993Experimental Treatment2 Interventions
Participants will be randomized to receive different dose levels of VX-993.
Group II: Hydrocodone bitartrate/acetaminophen (HB/APAP)Active Control2 Interventions
Participants will be randomized to receive HB/APAP.
Group III: PlaceboPlacebo Group2 Interventions
Participants will be randomized to receive placebos matched to VX-993 and HB/APAP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-993
2024
Completed Phase 1
~180
Placebo (matched to HB/APAP)
2021
Completed Phase 3
~2770
Find a Location
Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
257 Previous Clinical Trials
34,714 Total Patients Enrolled
8 Trials studying Acute Pain
3,621 Patients Enrolled for Acute Pain