Bunion on
your foot? Surgery on your mind?
If bunion surgery is your next step, the NAVISEEK Study may be an option for you. We’re evaluating an investigational drug for participants with pain after bunion surgery.
All eligible participants receive the following at no cost:
Participate in the NAVISEEK Study
Introducing the NAVISEEK Study
The NAVISEEK Study is a phase 2 clinical study looking at an investigational drug for the treatment of pain after bunion surgery. To qualify for this clinical study, you’ll first have a type of bunion surgery called an Austin bunionectomy. In this procedure, the surgeon will remove your bunion and straighten out the bones of your big toe. The surgery will be done under regional anesthesia, which means the surgeon will numb your foot so you can’t feel anything in that area. An intravenous medication may also be used to keep you comfortable during the surgery. If you meet certain criteria after surgery, you’ll begin taking your assigned study treatment, and we’ll see if the investigational drug is safe and effective in treating post-surgical pain.
About 355 people will participate in this study across the United States. If you’re eligible to participate, you’ll be randomly assigned—like flipping a coin—to 1 of 5 study treatment groups:
A low dose of the investigational drug.
A middle dose of the investigational drug.
A high dose of the investigational drug.
An approved pain medication.
Placebo (a pill that looks like the study drug but has no effect).
Can I
participate?
Take our prescreening questionnaire to see if you may be eligible to join the NAVISEEK Study.
What is the investigational drug?
The investigational drug works differently than currently available pain medications. We feel peripheral pain when pain receptor cells send signals through the nervous system to the brain. The investigational drug is designed to stop them from sending pain signals. We’re assessing multiple doses of the investigational drug, alongside standard pain medication and a placebo, to see which dose works best and has the fewest side effects.
What does participation
involve?
Participation in the NAVISEEK Study will require about 5 days in total at the research unit, including a Screening Visit, a 3-day stay in the research unit, and a Safety Follow-up Visit 14 days after your last dose of study treatment.
The clinical study includes the following parts:
Screening Visit: If you agree to be in this clinical study, you’ll sign the informed consent form (ICF). After signing, you’ll have tests done to see if you’re eligible to participate.
To qualify for the clinical study, you’ll be admitted to the research unit and have surgery to remove your bunion. Following surgery, the study team will check that you meet the study requirements to continue. If you do, you’ll be randomly assigned to 1 of the 5 study treatment groups.
Study Treatment Period: You’ll take your assigned study treatment orally 8 times over 2 days and report your pain levels to the study team. The study team will also perform testing to monitor your health and see how the study drug is working. In addition to your assigned study treatment, you may request ibuprofen if you require additional pain relief. On Day 3, you’ll be discharged from the research unit.
Safety Follow-up Visit: You’ll attend a Safety Follow-up Visit about 14 days after your last dose of study treatment. During this visit, the study team will check your health, check your wound, and end your study participation.
Who is eligible?
You may be able to join if:
You’re between the ages of 18 and 75.
You’re interested in having bunion surgery (bunionectomy).
You haven’t previously had bunion surgery or other surgeries on your affected foot.
What is a clinical study?
Clinical studies are designed to test investigational drugs to see if they’re safe and they work. They’re conducted by experienced medical professionals who monitor your health throughout the clinical study. They are also reviewed by the Food and Drug Administration (FDA), the Institutional Review Board (IRB), and ethics committees (ECs) to make sure they’re safe.
Clinical studies are the only way to develop new treatments and improve patient care. This clinical study will help researchers learn more about the safety and effectiveness of the investigational drug.
Frequently
asked questions
What bunion surgery is being done in this clinical study?
The type of bunion surgery being performed is an Austin bunionectomy. In this procedure, the surgeon will remove the excess bone of the bunion, and then make a cut in the bone, called an osteotomy, to straighten out the bones of your big toe. The surgery will be done under regional anesthesia, which means the surgeon will numb your foot so you can’t feel anything. An intravenous medication may also be used to keep you comfortable during the surgery.
How long will study participation last?
Participation in the NAVISEEK Study will require about 5 days in total at the research unit, including:
- A Screening Visit that will last about 4 hours.
- A 3-day inpatient stay that includes bunion surgery to qualify for the study and the Study Treatment Period.
- A Safety Follow-up Visit that will happen 14 days after your last dose of study treatment.
Will there be other tests and procedures in this clinical study?
In addition to having bunion surgery to qualify for the study and taking the study drug, you’ll have other tests and assessments throughout the clinical study to monitor your health and see how the study drug is working. These may include, but are not limited to, physical exams, blood and urine tests, vital signs measurement, and electrocardiograms (ECG). You’ll always be closely monitored by the study team.
What is a placebo?
A placebo looks like the investigational drug being tested, but it doesn’t have any active ingredients—meaning it won’t have any effect on you. In placebo-controlled research, one group is given the inactive treatment, while another group is given the active treatment to measure how the active treatment works. This clinical study also has a group that will receive a standard pain medication.
Is study participation voluntary?
Participation in any clinical study is completely voluntary. Your decision to participate or not participate in this clinical study will have no effect on the medical care that you receive now or in the future. If you’re eligible and choose to participate in the study, you may leave the clinical study at any time and for any reason.
How am I protected if I decide to participate?
Every clinical study must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the participant. As a volunteer, you have the right to discontinue your participation and leave the clinical study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled.
What is informed consent?
If you decide this clinical study is appropriate for you, the study doctor will explain the clinical study, answer any questions you have, and then ask you to review an informed consent form (ICF). This document will describe the clinical study, including its purpose, length, procedures, possible known risks and benefits of participating, and what is expected of you if you take part. After you have reviewed the ICF, you can decide whether or not to sign and volunteer to participate in the clinical study.
Is there compensation available?
You may receive up to $1,100 for your study-related time.
Will I be reimbursed for study-related expenses?
If you qualify, you’ll receive bunion surgery, the study drug, and any study procedures at no cost. You’ll also be reimbursed for reasonable meal, transportation, and parking costs. Please note that you and/or your insurance company will be responsible for the cost of any tests and procedures requested by your treating physician that fall outside of study activities. This includes any additional surgeries or revisions.
Are there side effects?
Like any drug or procedure, you may experience side effects from taking the study drug or undergoing study-related tests or procedures. You should let the study team know as soon possible if there any changes to your health.
Who is responsible for conducting this clinical study?
Vertex Pharmaceuticals Incorporated is responsible for this clinical study. To learn more, please visit vrtx.com.
Consider participating
Managing bunion pain can be difficult and limiting. If you’re considering bunion surgery, the NAVISEEK Study may be able to help you.