Acute Pain
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.
Interventions
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Before Surgery: * Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo block) After Surgery: * Participant is lucid and able to follow commands * All analgesic guidelines were followed during and after the bunionectomy Key
Exclusion criteria
Before Surgery: * Prior history of bunionectomy or other foot surgery on the index foot * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years * A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses After Surgery: * Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) | From 0 to 48 Hours After the First Dose of Study Drug |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants With >=50% Reduction in NPRS at 48 Hours | At 48 Hours After the First Dose of Study Drug |
| Proportion of Participants With >=70% Reduction in NPRS at 48 Hours | At 48 Hours After the First Dose of Study Drug |
| Maximum Observed Plasma Concentration (Cmax) of VX-993 and its Metabolite | Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug |
| Proportion of Participants With Greater Than or Equal To (>=) 30 Percent (%) Reduction in NPRS at 48 Hours | At 48 Hours After the First Dose of Study Drug |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-993 and its Metabolite | Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 19 |
| Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-993 and its Metabolite | Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug |
Countries
United States
Outcome results
None listed