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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Acetaminophen

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.