A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

VX22-548-105

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

2022-10-10

2023-08-25

2023-09-11

Completed

Early phase I

1118

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.

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2024-03-20