Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hisamitsu Pharmaceutical Co., Inc.
The objective of this study is to demonstrate the short-term multiple dose efficacy and safety of HKT-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. The goal of the study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 HKT-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.
Age
45–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
man or woman ≥45 years of age.
clinical diagnosis of unilateral or bilateral OA of the knee
taking an NSAID or acetaminophen on a regular basis and has a history of knee pain amelioration with NSAID or acetaminophen use.
mild to moderate OA of the knee at the screening visit
subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a NSAID or acetaminophen.
subject understands that treatment will be administered on an inpatient basis.
subject is capable of understanding and complying with the protocol and has signed the informed consent document.
You may not be if
subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
subject has symptoms that are attributable to primary inflammatory diseases of the joint
subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
subject has arthropathies that occur in conjunction with systemic diseases
subject has a chronic pain condition
subject is grossly obese
subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.
subject has a history of osteotomies.
subject is not willing to discontinue the use of NSAIDs, acetaminophen or other prohibited treatments
subject used opioids for OA pain within 1 month
Clareo Health | HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain
