A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Acetaminophen

Criteria

Key Inclusion Criteria:

• Before Surgery:

• Participant scheduled to undergo an abdominoplasty without collateral procedures

• After Surgery:

• Participant is lucid and able to follow commands

• All analgesic guidelines were followed during and after the abdominoplasty

• Abdominoplasty procedure duration <=3 hours without collateral procedures (for example., liposuction)

Key Exclusion Criteria

• Before Surgery:

• Prior history of abdominoplasty, intra-abdominal and/or pelvic surgery

• History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)

• Any prior surgery within 1 month before the first study drug

• After Surgery:

• Participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization

• Participant had collateral procedures during the abdominoplasty

Other protocol defined inclusion/exclusion criteria may apply