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VX-548 for Acute Pain

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
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 4 trial • 323 Patients • NCT01587274
6%
Nausea/ vomiting
5%
Stomach irritation
4%
Dizziness
4%
Drowsiness
3%
Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naproxen Alone
Opioid
Skeletal Muscle Relaxant

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
~3580
Placebo (matched to HB/APAP)
2021
Completed Phase 3
~2770

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
251 Previous Clinical Trials
32,590 Total Patients Enrolled
7 Trials studying Acute Pain
3,347 Patients Enrolled for Acute Pain
~66 spots leftby Sep 2025
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