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

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 2
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shoals Medical Trials Inc.
  • Arizona Research Center
  • Anaheim Clinical Trials
  • Lotus Clinical Research
  • New Hope Research Development
  • Atlanta Center for Medical Research
  • Chesapeake Research Group
  • Midwest Clinical Research Center
  • First Surgical Hospital
  • Legent Orthopedic Hospital
  • Endeavor Clinical Trials
  • JBR Clinical Research

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 different dose levels of VX-548.

Participants will receive HB/APAP.

Participants will receive placebos matched to VX-548 and HB/APAP.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time-weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) 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
Maximum Observed Plasma Concentration (Cmax) of VX-548
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Full Information

First Posted
July 15, 2021
Last Updated
February 16, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT04977336
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

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 doses in treating 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VX-548
Arm Type
Experimental
Arm Description
Participants will be randomized to receive different dose levels of VX-548.
Arm Title
Hydrocodone bitartrate/acetaminophen (HB/APAP)
Arm Type
Active Comparator
Arm Description
Participants will receive HB/APAP.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebos 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 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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Shoals Medical Trials Inc.
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Lotus Clinical Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
New Hope Research Development
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Chesapeake Research Group
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
First Surgical Hospital
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Legent Orthopedic Hospital
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

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

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

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