Clinical trial NCT05553366: Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 1075
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline to 48 Hours
Secondary outcomes:
measure: SPID48 Compared to HB/APAP
timeFrame: Baseline to 48 Hours
measure: Time to Greater than or Equal to (≥)2-Point Reduction in NPRS from Baseline Compared to Placebo
timeFrame: Baseline to 48 Hours
measure: Time to ≥1-Point Reduction in NPRS from Baseline Compared to Placebo
timeFrame: Baseline to 48 Hours
measure: Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo
timeFrame: At 48 Hours
measure: Incidence of Vomiting or Nausea Compared to HB/APAP
timeFrame: Baseline to Day 17
measure: Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo
timeFrame: Baseline to 24 hours
measure: Time to First Use of Rescue Medication Compared to Placebo
timeFrame: Baseline to 48 hours
measure: Proportion of Participants using Rescue Medication Compared to Placebo
timeFrame: Baseline to 48 hours
measure: Total Rescue Medication Usage Compared to Placebo
timeFrame: Baseline to 48 hours
measure: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to Day 17
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Shoals Medical Trials Inc.
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Bakersfield
country: United States
facility: Trovare Clinical Research
state: California
city: San Diego
country: United States
facility: Pacific Research Network Inc
state: California
city: Tarzana
country: United States
facility: New Hope Research Development
state: California
city: West Covina
country: United States
facility: New Hope Research Development
state: California
city: Hialeah
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Wichita
country: United States
facility: Kansas Spine and Specialty Hospital
state: Kansas
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Jenks
country: United States
facility: Center for Orthopaedic Reconstruction and Excellence
state: Oklahoma
city: Bellaire
country: United States
facility: HD Research LLC | First Surgical Hospital
state: Texas
city: Carrollton
country: United States
facility: HD Research LLC | Legent Orthopedic Hospital
state: Texas
city: Houston
country: United States
facility: HD Research LLC | Houston Heights Hospital
state: Texas
city: McAllen
country: United States
facility: Futuro Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Webster
country: United States
facility: Houston Physicians Hospital
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
References: