A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

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

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: VX-548; Drug: Placebo (matched to HB/APAP); Drug: HB/APAP; Drug: Placebo (matched to VX-548)

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research
  • Maryland
    • Pasadena, Maryland, United States, 21122
      • Chesapeake Research Group
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Texas
    • Bellaire, Texas, United States, 77401
      • First Surgical Hospital
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VX-548; Participants will be randomized to receive different dose levels of VX-548.	Drug: VX-548; Tablets for oral administration.; Drug: Placebo (matched to HB/APAP); Placebo matched to HB/APAP for oral administration.
Active Comparator: Hydrocodone bitartrate/ acetaminophen (HB/APAP); Participants will receive HB/APAP.	Drug: HB/APAP; Capsules for oral administration.; Drug: Placebo (matched to VX-548); Placebo matched to VX-548 for oral administration.
Placebo Comparator: Placebo; Participants will receive placebos matched to VX-548 and HB/APAP.	Drug: Placebo (matched to HB/APAP); Placebo matched to HB/APAP for oral administration.; Drug: Placebo (matched to VX-548); Placebo matched to VX-548 for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	0 to 48 Hours After the First Dose of Study Drug

Secondary Outcome Measures

Outcome Measure	Time Frame
Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug	0 to 24 Hours After the First Dose of Study Drug
Proportions of Participants With >=30 Percent (%), >=50%, and >=70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug	At 48 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 17

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): December 5, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: VX21-548-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No