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

Phase 3

Completed

• Conditions: Acute Pain
• Interventions: Drug: HB/APAP; Drug: VX-548; Drug: Placebo (matched to VX-548); Drug: Placebo (matched to HB/APAP)

• Registration Number: NCT05558410
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Study Start: 2022-10-10
• Primary Completion: 2023-08-25
• Study Completion: 2023-09-11
• Disposition First Posted: 2024-03-20
• Status Verified: 2024-08
• Disposition First Submitted: 2024-08-23
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocodone bitartrate/acetaminophen (HB/APAP)	HB/APAP	Participants will receive HB/APAP.
Hydrocodone bitartrate/acetaminophen (HB/APAP)	Placebo (matched to VX-548)	Participants will receive HB/APAP.
VX-548	VX-548	Participants will receive VX-548.
VX-548	Placebo (matched to HB/APAP)	Participants will receive VX-548.
Placebo	Placebo (matched to VX-548)	Participants will receive placebos matched to VX-548 and HB/APAP.
Placebo	Placebo (matched to HB/APAP)	Participants will receive placebos matched to VX-548 and HB/APAP.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (12)

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Shoals Medical Trials Inc.; 🇺🇸 Sheffield, Alabama, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

HD Research LLC | First Surgical Hospital; 🇺🇸 Bellaire, Texas, United States

Atlanta Center for Medical Research | Atlanta, GA; 🇺🇸 Atlanta, Georgia, United States

Kansas Spine and Specialty Hospital; 🇺🇸 Wichita, Kansas, United States

JBR Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

South Texas Spine & Surgical Hospital; 🇺🇸 San Antonio, Texas, United States

New Hope Research Development; 🇺🇸 Tarzana, California, United States

Woodland International Research Group; 🇺🇸 Little Rock, Arkansas, United States

Alliance Research Institute, LLC; 🇺🇸 Canoga Park, California, United States

HD Research LLC | Houston Heights Hospital; 🇺🇸 Houston, Texas, United States