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

• ClinicalTrials.gov Identifier: NCT05558410
• Recruitment Status: Completed
• First Posted: September 28, 2022
• Last Update Posted: March 20, 2024
• Sponsor: Vertex Pharmaceuticals Incorporated
• Information provided by (Responsible Party): Vertex Pharmaceuticals Incorporated

Tracking Information

• First Submitted Date: September 23, 2022
• First Posted Date: September 28, 2022
• Last Update Posted Date: March 20, 2024
• Actual Study Start Date: October 10, 2022
• Actual Primary Completion Date: August 25, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 23, 2022): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 23, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acute Pain

Intervention

• Drug: VX-548
  Tablets for oral administration.
  Other Name: Suzetrigine
• Drug: HB/APAP
  Capsules for oral administration.
• 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.

Study Arms

• Experimental: VX-548
  Participants will receive VX-548.
  Interventions:

  • Drug: VX-548
  • Drug: Placebo (matched to HB/APAP)
• Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP)
  Participants will receive HB/APAP.
  Interventions:

  • Drug: HB/APAP
  • Drug: Placebo (matched to VX-548)
• Placebo Comparator: Placebo
  Participants will receive placebos matched to VX-548 and HB/APAP.
  Interventions:

  • Drug: Placebo (matched to VX-548)
  • Drug: Placebo (matched to HB/APAP)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2023): 1118
• Original Estimated Enrollment (submitted: September 23, 2022): 1000
• Actual Study Completion Date: September 11, 2023
• Actual Primary Completion Date: August 25, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05558410
• Other Study ID Numbers: VX22-548-105
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

• Current Responsible Party: Vertex Pharmaceuticals Incorporated
• Original Responsible Party: Same as current
• Current Study Sponsor: Vertex Pharmaceuticals Incorporated
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Vertex Pharmaceuticals Incorporated
• Verification Date: March 2024