A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

• Status: Recruiting
• Trial end date: 2022-01-01
• 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 a bunionectomy.

• 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 a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)

• After Surgery:

• Participant is lucid and able to follow commands

• All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

• Before Surgery:

• Prior history of bunionectomy or other foot surgery on the index foot

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

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

• After Surgery:

• Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Other protocol defined inclusion/exclusion criteria may apply