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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05558410
Recruitment Status : Completed
First Posted : September 28, 2022
Last Update Posted : March 20, 2024
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of VX-548 in treating acute pain after an abdominoplasty.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: VX-548 Drug: HB/APAP Drug: Placebo (matched to VX-548) Drug: Placebo (matched to HB/APAP) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2022
Actual Primary Completion Date : August 25, 2023
Actual Study Completion Date : September 11, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: VX-548
Participants will receive VX-548.
 Drug: VX-548
Tablets for oral administration.
Other Name: Suzetrigine

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 VX-548)
Placebo matched to VX-548 for oral administration.

Drug: Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. SPID48 Compared to HB/APAP [ Time Frame: Baseline to 48 Hours ]
  2. Time to Greater than or Equal to (≥) 2-point Reduction in NPRS from Baseline Compared to Placebo [ Time Frame: Baseline to 48 Hours ]
  3. Time to ≥1-point Reduction in NPRS from Baseline Compared to Placebo [ Time Frame: Baseline to 48 Hours ]
  4. Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo [ Time Frame: At 48 hours ]
  5. Incidence of Vomiting or Nausea Compared to HB/APAP [ Time Frame: Baseline to Day 17 ]
  6. Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo [ Time Frame: Baseline to 24 hours ]
  7. Time to First Use of Rescue Medication Compared to Placebo [ Time Frame: Baseline to 48 hours ]
  8. Proportion of Participants using Rescue Medication Compared to Placebo [ Time Frame: Baseline to 48 hours ]
  9. Total Rescue Medication Usage Compared to Placebo [ Time Frame: Baseline to 48 hours ]
  10. Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to Day 17 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558410


Locations
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United States, Alabama
Shoals Medical Trials Inc.
Sheffield, Alabama, United States, 35660
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85053
United States, Arkansas
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
United States, California
Alliance Research Institute, LLC
Canoga Park, California, United States, 91304
New Hope Research Development
Tarzana, California, United States, 91356
United States, Georgia
Atlanta Center for Medical Research | Atlanta, GA
Atlanta, Georgia, United States, 30331
United States, Kansas
Kansas Spine and Specialty Hospital
Wichita, Kansas, United States, 67226
United States, Texas
HD Research LLC | First Surgical Hospital
Bellaire, Texas, United States, 77401
HD Research LLC | Houston Heights Hospital
Houston, Texas, United States, 77008
Endeavor Clinical Trials
San Antonio, Texas, United States, 78240
South Texas Spine & Surgical Hospital
San Antonio, Texas, United States, 78258
United States, Utah
JBR Clinical Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
More Information
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT05558410    
Other Study ID Numbers: VX22-548-105
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Acetaminophen
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics