Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of VX-548 for acute pain after a bunionectomy.

Official Title
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A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: VX-548
* Drug: HB/APAP
* Drug: Placebo (matched to VX-548)
* Drug: Placebo (matched to HB/APAP)


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Before Surgery Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic 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 or other foot surgery on the index foot; or bunionectomy on the opposite foot History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s) Any prior surgery within 1 month before the first study drug dose After Surgery Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VX-548<br>Participants will be randomized to receive VX-548. | Drug: VX-548<br>* Tablets for oral administration.<br>Drug: Placebo (matched to HB/APAP)<br>* Placebo matched to HB/APAP for oral administration.<br>|
| Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP)<br>Participants will be randomized to receive HB/APAP. | Drug: HB/APAP<br>* Capsules for oral administration.<br>Drug: Placebo (matched to VX-548)<br>* Placebo matched to VX-548 for oral administration.<br>|
| Placebo Comparator: Placebo<br>Participants will be randomized to receive placebo matched to VX-548 and HB/APAP. | Drug: Placebo (matched to VX-548)<br>* Placebo matched to VX-548 for oral administration.<br>Drug: Placebo (matched to HB/APAP)<br>* Placebo matched to HB/APAP for oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) Compared to Placebo |  | Baseline to 48 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPID48 Compared to HB/APAP |  | Baseline to 48 Hours | 
| Time to Greater than or Equal to (≥)2-Point Reduction in NPRS from Baseline Compared to Placebo |  | Baseline to 48 Hours | 
| Time to ≥1-Point Reduction in NPRS from Baseline Compared to Placebo |  | Baseline to 48 Hours | 
| Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo |  | At 48 Hours | 
| Incidence of Vomiting or Nausea Compared to HB/APAP |  | Baseline to Day 17 | 
| Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo |  | Baseline to 24 hours | 
| Time to First Use of Rescue Medication Compared to Placebo |  | Baseline to 48 hours | 
| Proportion of Participants using Rescue Medication Compared to Placebo |  | Baseline to 48 hours | 
| Total Rescue Medication Usage Compared to Placebo |  | Baseline to 48 hours | 
| Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Baseline to Day 17 |