Evaluating VX-993 for pain relief after bunion surgery
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
This study is testing a new pain relief medication called VX-993 for people who have just had bunion surgery to see if it works better than a common painkiller.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 355 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Vertex Pharmaceuticals Incorporated Industry-sponsored |
| Locations | 14 sites (Sheffield, Alabama and 13 other locations) |
| Trial ID | NCT06619847 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for a primary unilateral bunionectomy under regional anesthesia.
Not a fit: Patients with a history of bunionectomy on the same foot or those with significant medical complications during surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new effective treatment for managing acute pain after bunion surgery.
How similar studies have performed: Other studies evaluating similar pain management approaches have shown promise, but the specific use of VX-993 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Sheffield, Alabama and 13 other locations
- Shoals Medical Trials Inc. — Sheffield, Alabama, United States (Recruiting)
- Arizona Research Center — Phoenix, Arizona, United States (Completed)
- Woodland International Research Group — Little Rock, Arkansas, United States (Completed)
- Trovare Clinical Research — Bakersfield, California, United States (Recruiting)
- New Hope Research Development | Tarzana, CA — Tarzana, California, United States (Completed)
- Clinical Pharmacology of Miami — Miami, Florida, United States (Completed)
- ForCare Clinical Research — Tampa, Florida, United States (Completed)
- Atlanta Center for Medical Research — Atlanta, Georgia, United States (Completed)
- BioBehavioral Research of Austin — Austin, Texas, United States (Completed)
- HD Research LLC | First Surgical Hospital — Bellaire, Texas, United States (Completed)
- HD Research LLC | Legent Orthopedic Hospital — Carrollton, Texas, United States (Completed)
- Memorial Hermann Village — Houston, Texas, United States (Completed)
- Endeavor Clinical Trials — San Antonio, Texas, United States (Completed)
- JBR Clinical Research — Salt Lake City, Utah, United States (Completed)
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.