A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

February 16, 2023 updated by: Vertex Pharmaceuticals Incorporated

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Shoals Medical Trials Inc.
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
      • Pasadena, California, United States, 91105
        • Lotus Clinical Research
      • Tarzana, California, United States, 91356
        • New Hope Research Development
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical 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
      • Carrollton, Texas, United States, 75006
        • Legent Orthopedic Hospital
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 0 to 48 Hours 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 a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug
Time Frame: 0 to 24 Hours 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 48 Hours After the First Dose of Study Drug
Time Frame: At 48 Hours After the First Dose of Study Drug
At 48 Hours After the First Dose of Study Drug
Maximum Observed Plasma Concentration (Cmax) of VX-548
Time Frame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548
Time Frame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548
Time Frame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Pre-dose to 12 Hours and 24 to 36 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)
Time Frame: Day 1 up to Day 18
Day 1 up to Day 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2021

Primary Completion (Actual)

February 17, 2022

Study Completion (Actual)

March 4, 2022

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 26, 2021

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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