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Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

Primary Purpose

Acute Pain

Status
Completed
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

    • Participant scheduled to undergo a standard ("full") abdominoplasty procedure

  • After Surgery

    • Participant is lucid and able to follow commands and able to swallow oral medications
    • All analgesic guidelines were followed during and after the abdominoplasty
    • Abdominoplasty procedure duration less than or equal to (≤3) hours

Key Exclusion Criteria:

  • Before Surgery

    • Prior history of abdominoplasty
    • History of Intra-abdominal and/or pelvic surgery that resulted into complications
    • 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 non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty
    • Participant had a medical complication during the abdominoplasty 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
  • Woodland International Research Group
  • Alliance Research Institute, LLC
  • New Hope Research Development
  • Atlanta Center for Medical Research | Atlanta, GA
  • Kansas Spine and Specialty Hospital
  • HD Research LLC | First Surgical Hospital
  • HD Research LLC | Houston Heights Hospital
  • Endeavor Clinical Trials
  • South Texas Spine & Surgical Hospital
  • 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 receive 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 the Pain Intensity Difference (SPID) as Recorded on the 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 23, 2022
Last Updated
September 21, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05558410
Brief Title
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
August 25, 2023 (Actual)
Study Completion Date
September 11, 2023 (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 in treating acute pain after an abdominoplasty.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VX-548
Arm Type
Experimental
Arm Description
Participants will receive 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 the Pain Intensity Difference (SPID) as Recorded on the 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 Participant scheduled to undergo a standard ("full") abdominoplasty procedure After Surgery Participant is lucid and able to follow commands and able to swallow oral medications All analgesic guidelines were followed during and after the abdominoplasty Abdominoplasty procedure duration less than or equal to (≤3) hours Key Exclusion Criteria: Before Surgery Prior history of abdominoplasty History of Intra-abdominal and/or pelvic surgery that resulted into complications 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 non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty Participant had a medical complication during the abdominoplasty 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
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Alliance Research Institute, LLC
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
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 | Atlanta, GA
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Kansas Spine and Specialty Hospital
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
HD Research LLC | First Surgical Hospital
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
HD Research LLC | Houston Heights Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
South Texas Spine & Surgical Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
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

Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

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