Evaluating VX-993 for pain relief after bunion surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy, safety, tolerability, and pharmacokinetics of VX-993 in patients experiencing acute pain following a bunionectomy. Participants will receive either VX-993, a combination of hydrocodone and acetaminophen (HB/APAP), or a placebo. The study will monitor participants before and after surgery to ensure they meet specific inclusion criteria and to evaluate their pain management outcomes. The approach focuses on providing a new treatment option for post-surgical pain relief.

Why it matters

Who can join: the full rules

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 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) within the last 2 years
* A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses

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

Other protocol defined inclusion/exclusion criteria may apply.

Where it's running

• Shoals Medical Trials Inc.
  Sheffield, Alabama, United States Recruiting
• Trovare Clinical Research
  Bakersfield, California, United States Recruiting
• Arizona Research Center
  Phoenix, Arizona, United States Completed
• Woodland International Research Group
  Little Rock, Arkansas, United States Completed
• New Hope Research Development | Tarzana, CA
  Tarzana, California, United States Completed
• Clinical Pharmacology of Miami
  Miami, Florida, United States Completed

Study contacts

• Study coordinator: Medical Information
• Email: medicalinfo@vrtx.com
• Phone: 617-341-6777

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.