Summary:
A clinical research study for people planning to undergo a bunion repair procedure under local anesthesia.
The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication, called VX-548, in individuals experiencing acute pain after a bunion repair procedure. This clinical research study is part of the Vertex pain research program, which is developing medicines aimed at selectively targeting the underlying cause of the pain response. The total length of study participation will last approximately six weeks and includes a four-week screening period (with a one-week extension in some cases) consisting of one visit, which can be conducted at home; a four-day study treatment period consisting of one overnight visit that will last at least 48 hours after the procedure; and a safety follow-up visit approximately 14 days after a participant’s final dose of study treatment, which can be done at home or at the study site.
If you qualify for this clinical research study, you will receive all study-related medications and procedures at no cost. You and your study doctor may choose to have some of the study visits at your home with a home health nurse, allowing for a reduced number of times that you must travel to the study site. You may also be compensated financially for your study-related time and reimbursed for travel.
Key inclusion criteria for this study:
- 18 to 80 years of age (inclusive)
- No prior history of bunion repair surgery or other foot surgery on the index foot; or bunion repair surgery on the opposite foot as part of this study or prior Vertex study
- Willing and able to comply with study instructions
Other inclusion and exclusion criteria may apply.