Clinical trial NCT04977336: A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 doses in treating acute pain after a bunionectomy.


Eligibility 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 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 other foot surgery on the index foot
  * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  * Any prior surgery within 1 month before the first study drug
* 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 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 Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug
timeFrame: 0 to 48 Hours After the First Dose of Study Drug
Secondary outcomes:
measure: Time-weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug
timeFrame: 0 to 24 Hours After the First Dose of Study Drug
measure: Proportions of Participants With >=30 Percent (%), >=50%, and >=70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug
timeFrame: At 48 Hours After the First Dose of Study Drug
measure: Maximum Observed Plasma Concentration (Cmax) of VX-548
timeFrame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548
timeFrame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
measure: Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548
timeFrame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 18
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: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: Tarzana
country: United States
facility: New Hope Research Development
state: California
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Pasadena
country: United States
facility: Chesapeake Research Group
state: Maryland
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Bellaire
country: United States
facility: First Surgical Hospital
state: Texas
city: Carrollton
country: United States
facility: Legent Orthopedic Hospital
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
References: