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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 pre-dose to 12 hours and 24 to 36 hours after the first dose of study drug
Awards & highlights

Summary

This study is evaluating whether a drug called VX-548 can help reduce pain after a bunionectomy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose to 12 hours and 24 to 36 hours after the first dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose to 12 hours and 24 to 36 hours after the first dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time-weighted sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug
Secondary outcome measures
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548
Maximum Observed Plasma Concentration (Cmax) of VX-548
Proportions of Participants With >=30 Percent (%), >=50%, and >=70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug
+3 more

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
~3540
Placebo (matched to HB/APAP)
2021
Completed Phase 3
~2770

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
247 Previous Clinical Trials
32,329 Total Patients Enrolled
7 Trials studying Acute Pain
3,347 Patients Enrolled for Acute Pain
~68 spots leftby Jul 2025