A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 367
- Locations
- 28
- Primary Endpoint
- Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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/exclusion criteria may apply.
Arms & Interventions
VX-993
Participants will be randomized to receive different dose levels of VX-993.
Intervention: Placebo (matched to HB/APAP) (Drug)
Hydrocodone bitartrate/acetaminophen (HB/APAP)
Participants will be randomized to receive HB/APAP.
Intervention: HB/APAP (Drug)
Hydrocodone bitartrate/acetaminophen (HB/APAP)
Participants will be randomized to receive HB/APAP.
Intervention: Placebo (matched to VX-993) (Drug)
Placebo
Participants will be randomized to receive placebo matched to VX-993 and HB/APAP
Intervention: Placebo (matched to VX-993) (Drug)
Placebo
Participants will be randomized to receive placebo matched to VX-993 and HB/APAP
Intervention: Placebo (matched to HB/APAP) (Drug)
VX-993
Participants will be randomized to receive different dose levels of VX-993.
Intervention: VX-993 (Drug)
Outcomes
Primary Outcomes
Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48)
Time Frame: From 0 to 48 Hours After the First Dose of Study Drug
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)