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A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Dayton, OH
Phase 2
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing a medication called VX-548 to see if it can reduce pain in patients who have had bunion surgery by blocking pain signals.
See full description
Eligible Conditions
- Acute Pain
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
Side effects data
From 2021 Phase 2 trial • 303 Patients • NCT0503495230%
Nausea
12%
Constipation
11%
Dizziness
11%
Vomiting
7%
Headache
4%
Hypotension
3%
Hyperhidrosis
1%
Hypoxia
1%
Laryngeal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
HB/APAP
VX-548 High Dose
VX-548 Low Dose
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: VX-548Experimental Treatment2 Interventions
Participants will be randomized to receive different dose levels of VX-548.
Group II: Hydrocodone bitartrate/acetaminophen (HB/APAP)Active Control2 Interventions
Participants will receive HB/APAP.
Group III: PlaceboPlacebo Group2 Interventions
Participants will receive placebos matched to VX-548 and HB/APAP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-548
2022
Completed Phase 3
~3750
Placebo (matched to HB/APAP)
2021
Completed Phase 3
~2770
Find a Location
Closest Location:Midwest Clinical Research Center· Dayton, OH
Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
263 Previous Clinical Trials
35,469 Total Patients Enrolled
8 Trials studying Acute Pain
3,702 Patients Enrolled for Acute Pain