Clinical trial NCT05034952: A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-dose Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 303
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 an abdominoplasty.


Eligibility criteria: Key Inclusion Criteria:

* Before Surgery:

  * Participant scheduled to undergo an abdominoplasty without collateral procedures
* After Surgery:

  * Participant is lucid and able to follow commands
  * All analgesic guidelines were followed during and after the abdominoplasty
  * Abdominoplasty procedure duration \<=3 hours without collateral procedures (for example., liposuction)

Key Exclusion Criteria

* Before Surgery:

  * Prior history of abdominoplasty, intra-abdominal and/or pelvic surgery
  * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  * Any prior surgery within 1 month before the first study drug
* After Surgery:

  * Participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
  * Participant had collateral procedures during the abdominoplasty

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) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug
timeFrame: 0 to 48 Hours After First Dose of Study Drug
Secondary outcomes:
measure: Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug
timeFrame: 0 to 24 Hours After First Dose of Study Drug
measure: Percentage of Participants With at Least 30 Percent (%),Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
timeFrame: From Baseline At 48 Hours After First Dose of Study Drug
measure: Percentage of Participants With at Least 50% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
timeFrame: From Baseline At 48 Hours After First Dose of Study Drug
measure: Percentage of Participants With at Least 70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
timeFrame: From Baseline at 48 Hours After First Dose of Study Drug
measure: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
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: 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: