Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Prior to Surgery:
Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure
After Surgery:
Subject reported pain of ≥4 on the NPRS, and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
Subject is lucid and able to follow commands
All analgesic guidelines were followed during and after the bunionectomy
You may not be if
Prior to Surgery:
History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
History of abnormal laboratory results ≥2.5 × upper limit of normal (ULN)
History of peripheral neuropathy
A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
Prior medical history of bunionectomy or other foot surgery
Intolerant of or unwilling to receive hydrocodone, acetaminophen, or ibuprofen
For female subjects: Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
For male subjects: Male subjects with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
After Surgery:
Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization
Clareo Health | A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
