Summary:
A clinical research study for people planning to undergo a full tummy tuck procedure.
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 tummy tuck 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 first dose of study treatment will occur within four hours of the end of the tummy tuck procedure. The total length of study participation will last approximately seven 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 three-day treatment period consisting of one overnight visit that will last at least 48 hours after the first dose of study treatment; and a safety follow-up visit, which will be conducted at the study site 12–16 days after a participant’s last dose of study treatment.
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 tummy tuck surgery
- No prior history of intra-abdominal surgery or pelvic surgery that resulted in complications
- No history of peptic ulcer disease or sleep apnea
- Be willing and able to comply with study instructions
Other inclusion and exclusion criteria may apply.