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A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
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 safely and effectively reduce pain in people who have had tummy tuck surgery.
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
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
~3790
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
34,751 Total Patients Enrolled
8 Trials studying Acute Pain
3,673 Patients Enrolled for Acute Pain