Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

• 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 for acute pain after a bunionectomy.

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

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Acetaminophen

Criteria

Key Inclusion Criteria:

• Before Surgery

• Participants 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 or other foot surgery on the index foot; or bunionectomy on the opposite foot

• 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 type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy

• Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Other protocol defined Inclusion/Exclusion criteria may apply.