- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05558410
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
March 18, 2024 updated by: Vertex Pharmaceuticals Incorporated
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
The purpose of this study is to evaluate the efficacy and safety of VX-548 in treating acute pain after an abdominoplasty.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1118
Phase
- Phase 3
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
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Alabama
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Sheffield, Alabama, United States, 35660
- Shoals Medical Trials Inc.
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Arizona
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Phoenix, Arizona, United States, 85053
- Arizona Research Center
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Woodland International Research Group
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California
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Canoga Park, California, United States, 91304
- Alliance Research Institute, LLC
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Tarzana, California, United States, 91356
- New Hope Research Development
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Georgia
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Atlanta, Georgia, United States, 30331
- Atlanta Center for Medical Research | Atlanta, GA
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Kansas
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Wichita, Kansas, United States, 67226
- Kansas Spine and Specialty Hospital
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Texas
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Bellaire, Texas, United States, 77401
- HD Research LLC | First Surgical Hospital
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Houston, Texas, United States, 77008
- HD Research LLC | Houston Heights Hospital
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San Antonio, Texas, United States, 78240
- Endeavor Clinical Trials
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San Antonio, Texas, United States, 78258
- South Texas Spine & Surgical Hospital
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Utah
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Salt Lake City, Utah, United States, 84107
- JBR Clinical Research
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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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
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 |
---|---|
Placebo Comparator: Placebo
Participants will receive placebos matched to VX-548 and HB/APAP.
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Placebo matched to HB/APAP for oral administration.
Placebo matched to VX-548 for oral administration.
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Experimental: VX-548
Participants will receive VX-548.
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Tablets for oral administration.
Other Names:
Placebo matched to HB/APAP for oral administration.
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Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP)
Participants will receive HB/APAP.
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Capsules for oral administration.
Placebo matched to VX-548 for oral administration.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Baseline to 48 Hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SPID48 Compared to HB/APAP
Time Frame: Baseline to 48 Hours
|
Baseline to 48 Hours
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Incidence of Vomiting or Nausea Compared to HB/APAP
Time Frame: Baseline to Day 17
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Baseline to Day 17
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Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo
Time Frame: Baseline to 24 hours
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Baseline to 24 hours
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Time to First Use of Rescue Medication Compared to Placebo
Time Frame: Baseline to 48 hours
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Baseline to 48 hours
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Proportion of Participants using Rescue Medication Compared to Placebo
Time Frame: Baseline to 48 hours
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Baseline to 48 hours
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Total Rescue Medication Usage Compared to Placebo
Time Frame: Baseline to 48 hours
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Baseline to 48 hours
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Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline to Day 17
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Baseline to Day 17
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Time to Greater than or Equal to (≥) 2-point Reduction in NPRS from Baseline Compared to Placebo
Time Frame: Baseline to 48 Hours
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Baseline to 48 Hours
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Time to ≥1-point Reduction in NPRS from Baseline Compared to Placebo
Time Frame: Baseline to 48 Hours
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Baseline to 48 Hours
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Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo
Time Frame: At 48 hours
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At 48 hours
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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)
October 10, 2022
Primary Completion (Actual)
August 25, 2023
Study Completion (Actual)
September 11, 2023
Study Registration Dates
First Submitted
September 23, 2022
First Submitted That Met QC Criteria
September 23, 2022
First Posted (Actual)
September 28, 2022
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VX22-548-105
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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