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

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05558410
• Other study ID #: VX22-548-105
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2022
• Est. completion date: September 11, 2023

Study information

• Verified date: March 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1118
• Est. completion date: September 11, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• VX-548
Tablets for oral administration.
• HB/APAP
Capsules for oral administration.
• Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
• Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research | Atlanta, GA	Atlanta	Georgia
United States	HD Research LLC | First Surgical Hospital	Bellaire	Texas
United States	Alliance Research Institute, LLC	Canoga Park	California
United States	HD Research LLC | Houston Heights Hospital	Houston	Texas
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Arizona Research Center	Phoenix	Arizona
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	South Texas Spine & Surgical Hospital	San Antonio	Texas
United States	Shoals Medical Trials Inc.	Sheffield	Alabama
United States	New Hope Research Development	Tarzana	California
United States	Kansas Spine and Specialty Hospital	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline to 48 Hours
Secondary	SPID48 Compared to HB/APAP		Baseline to 48 Hours
Secondary	Time to Greater than or Equal to (=) 2-point Reduction in NPRS from Baseline Compared to Placebo		Baseline to 48 Hours
Secondary	Time to =1-point Reduction in NPRS from Baseline Compared to Placebo		Baseline to 48 Hours
Secondary	Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo		At 48 hours
Secondary	Incidence of Vomiting or Nausea Compared to HB/APAP		Baseline to Day 17
Secondary	Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo		Baseline to 24 hours
Secondary	Time to First Use of Rescue Medication Compared to Placebo		Baseline to 48 hours
Secondary	Proportion of Participants using Rescue Medication Compared to Placebo		Baseline to 48 hours
Secondary	Total Rescue Medication Usage Compared to Placebo		Baseline to 48 hours
Secondary	Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)		Baseline to Day 17