Acute Pain Clinical Trial Following Abdominoplasty Surgery
Purpose of the Navigate-2 Study
The purpose of the NAVIGATE-2 Study is to evaluate the safety and effectiveness of an investigational study drug, called VX-548, in people experiencing acute pain after a tummy tuck (abdominoplasty) 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.
Who May Qualify
Eligible participants must:
- Be 18 to 80 years of age (inclusive)
- Not have a prior history of tummy tuck surgery
- Not have a prior history of intra-abdominal surgery or pelvic surgery that resulted in complications
- Not have a history of peptic ulcer disease or sleep apnea
- Be willing and able to comply with study instructions
There are additional eligibility requirements, which the study doctor can explain to you.
Participation in the NAVIGATE-2 Study will last approximately seven weeks. During this time, participants will visit the study site once for their tummy tuck procedure and may have up to three clinic visits or home health visits.
Can be up to four weeks (with a one-week extension in some cases) and usually consists of one visit. This visit has the option of being conducted at the clinic or through a home health visit. The purpose of this period is to evaluate all interested individuals to see if they meet the eligibility requirements.
Lasts approximately three days. Participants will be admitted to the clinical research unit the day of their tummy tuck procedure and will remain in the clinical research unit until at least 48 hours after the first dose of study drug. During this period, participants will take their assigned study treatment every six hours. The study team will monitor the participants’ health and pain levels throughout this period.
Safety follow-up visit
This visit takes place approximately 12–16 days after the last dose of study drug and will be conducted at the study site. The purpose of this visit is for the study team to check on participants’ health after they stop taking the study drug and to ensure the surgical wound is healing properly.
About the Study Drug
Researchers are investigating the safety and effectiveness of the investigational study drug, VX-548, in adults with acute pain post–tummy tuck. VX-548 is intended to block one of the channels that plays a critical role in signaling pain to the nervous system. A study drug is a medication that is not yet approved for use by the Food and Drug Administration (FDA) in the United States or other regulatory agencies in Canada, Europe, or elsewhere.
There are three treatment groups in this study, with one group receiving VX-548, one group receiving a comparator drug (an FDA-approved treatment for pain: hydrocodone bitartrate combined with acetaminophen), and one group receiving a placebo (a substance that looks like the study drug but contains no active ingredients). The use of a placebo in this study will help the researchers by providing a baseline to compare the study medication to. Each participant will be assigned randomly to one of the groups and will take oral tablets or capsules of their assigned study treatment every six hours with water. During the study, neither the participant nor the study doctor will know which group they are in, but in case of emergency, the study doctor can quickly find out.