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Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Primary Purpose

Acute Pain

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VX-548
HB/APAP
Placebo (matched to VX-548)
Placebo (matched to HB/APAP)
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shoals Medical Trials Inc.Recruiting
  • Arizona Research CenterRecruiting
  • Woodland International Research GroupRecruiting
  • Anaheim Clinical TrialsRecruiting
  • Trovare Clinical ResearchRecruiting
  • Alliance Research Institute, LLC
  • Pacific Research Network IncRecruiting
  • New Hope Research DevelopmentRecruiting
  • New Hope Research Development
  • Clinical Pharmacology of MiamiRecruiting
  • ForCare Clinical ResearchRecruiting
  • Atlanta Center for Medical ResearchRecruiting
  • Kansas Spine and Specialty HospitalRecruiting
  • OrthoNebraska Hospital
  • Midwest Clinical Research Center
  • Center for Orthopaedic Reconstruction and ExcellenceRecruiting
  • HD Research LLC | First Surgical HospitalRecruiting
  • HD Research LLC | Legent Orthopedic HospitalRecruiting
  • HD Research LLC | Houston Heights HospitalRecruiting
  • Futuro Clinical TrialsRecruiting
  • Endeavor Clinical TrialsRecruiting
  • Houston Physicians HospitalRecruiting
  • JBR Clinical ResearchRecruiting
  • Wasatch Clinical Research | Salt Lake City, UT

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

VX-548

Hydrocodone bitartrate/acetaminophen (HB/APAP)

Placebo

Arm Description

Participants will be randomized to receive VX-548.

Participants will be randomized to receive HB/APAP.

Participants will be randomized to receive placebo matched to VX-548 and HB/APAP.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SPID48 Compared to HB/APAP
Time to Greater than or Equal to (≥)2-Point Reduction in NPRS from Baseline Compared to Placebo
Time to ≥1-Point Reduction in NPRS from Baseline Compared to Placebo
Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo
Incidence of Vomiting or Nausea Compared to HB/APAP
Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo
Time to First Use of Rescue Medication Compared to Placebo
Proportion of Participants using Rescue Medication Compared to Placebo
Total Rescue Medication Usage Compared to Placebo
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Full Information

First Posted
September 20, 2022
Last Updated
October 13, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05553366
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VX-548
Arm Type
Experimental
Arm Description
Participants will be randomized to receive VX-548.
Arm Title
Hydrocodone bitartrate/acetaminophen (HB/APAP)
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive HB/APAP.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive placebo matched to VX-548 and HB/APAP.
Intervention Type
Drug
Intervention Name(s)
VX-548
Intervention Description
Tablets for oral administration.
Intervention Type
Drug
Intervention Name(s)
HB/APAP
Intervention Description
Capsules for oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo (matched to VX-548)
Intervention Description
Placebo matched to VX-548 for oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo (matched to HB/APAP)
Intervention Description
Placebo matched to HB/APAP for oral administration.
Primary Outcome Measure Information:
Title
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
Time Frame
Baseline to 48 Hours
Secondary Outcome Measure Information:
Title
SPID48 Compared to HB/APAP
Time Frame
Baseline to 48 Hours
Title
Time to Greater than or Equal to (≥)2-Point Reduction in NPRS from Baseline Compared to Placebo
Time Frame
Baseline to 48 Hours
Title
Time to ≥1-Point Reduction in NPRS from Baseline Compared to Placebo
Time Frame
Baseline to 48 Hours
Title
Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo
Time Frame
At 48 Hours
Title
Incidence of Vomiting or Nausea Compared to HB/APAP
Time Frame
Baseline to Day 17
Title
Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo
Time Frame
Baseline to 24 hours
Title
Time to First Use of Rescue Medication Compared to Placebo
Time Frame
Baseline to 48 hours
Title
Proportion of Participants using Rescue Medication Compared to Placebo
Time Frame
Baseline to 48 hours
Title
Total Rescue Medication Usage Compared to Placebo
Time Frame
Baseline to 48 hours
Title
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Baseline to Day 17

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Information
Phone
617-341-6777
Email
medicalinfo@vrtx.com
Facility Information:
Facility Name
Shoals Medical Trials Inc.
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Name
Trovare Clinical Research
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance Research Institute, LLC
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
Country
United States
Individual Site Status
Withdrawn
Facility Name
Pacific Research Network Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
New Hope Research Development
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Individual Site Status
Recruiting
Facility Name
New Hope Research Development
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Pharmacology of Miami
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Name
Kansas Spine and Specialty Hospital
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Name
OrthoNebraska Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Individual Site Status
Withdrawn
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Completed
Facility Name
Center for Orthopaedic Reconstruction and Excellence
City
Jenks
State/Province
Oklahoma
ZIP/Postal Code
74037
Country
United States
Individual Site Status
Recruiting
Facility Name
HD Research LLC | First Surgical Hospital
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
HD Research LLC | Legent Orthopedic Hospital
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Individual Site Status
Recruiting
Facility Name
HD Research LLC | Houston Heights Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Name
Futuro Clinical Trials
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Individual Site Status
Recruiting
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Physicians Hospital
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Wasatch Clinical Research | Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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

Learn more about this trial

Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

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