Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
NCT05553366 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1075
Last updated 2025-08-01
Summary
The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.
Conditions
- Acute Pain
Interventions
- DRUG
-
SUZ
Tablets for oral administration.
- DRUG
-
HB/APAP
Capsules for oral administration.
- DRUG
-
Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
- DRUG
-
Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-03
- Primary Completion
- 2023-12-15
- Completion
- 2023-12-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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