Age
Item
man or woman ≥45 years of age.
boolean
C0001779 (UMLS CUI [1])
Unilateral primary osteoarthritis of knee | Bilateral primary osteoarthritis of knee
Item
clinical diagnosis of unilateral or bilateral oa of the knee
boolean
C2893932 (UMLS CUI [1])
C2893930 (UMLS CUI [2])
NSAID Regular | Acetaminophen Regular | Medical History Knee pain improved by NSAIDs | Medical History Knee pain improved by Acetaminophen
Item
taking an nsaid or acetaminophen on a regular basis and has a history of knee pain amelioration with nsaid or acetaminophen use.
boolean
C0003211 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0000970 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C2110474 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C2110472 (UMLS CUI [4,2])
C0000970 (UMLS CUI [4,3])
Knee Osteoarthritis Mild | Knee Osteoarthritis Moderate
Item
mild to moderate oa of the knee at the screening visit
boolean
C0409959 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0409959 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
Arthritis flare up Index Knee | NSAID Withdrawal | Acetaminophen Withdrawal
Item
subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a nsaid or acetaminophen.
boolean
C0857103 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C0000970 (UMLS CUI [3,1])
C2349954 (UMLS CUI [3,2])
Comprehension Inpatient treatment
Item
subject understands that treatment will be administered on an inpatient basis.
boolean
C0162340 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Protocol Compliance | Informed Consent
Item
subject is capable of understanding and complying with the protocol and has signed the informed consent document.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Childbearing Potential Urine pregnancy test positive | Childbearing Potential Breast Feeding | Childbearing Potential Female Sterilization Absent
Item
subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
boolean
C3831118 (UMLS CUI [1,1])
C0430059 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0015787 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Symptoms Inflammatory joint disease Primary
Item
subject has symptoms that are attributable to primary inflammatory diseases of the joint
boolean
C1457887 (UMLS CUI [1,1])
C0683381 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Unstable knee Physical Examination | Knee catches during movement | Knee Giving-way
Item
subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
boolean
C0427262 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C2109427 (UMLS CUI [2])
C0022742 (UMLS CUI [3,1])
C0231748 (UMLS CUI [3,2])
Arthropathies Associated with Systemic disease
Item
subject has arthropathies that occur in conjunction with systemic diseases
boolean
C0022408 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0442893 (UMLS CUI [1,3])
Chronic pain
Item
subject has a chronic pain condition
boolean
C0150055 (UMLS CUI [1])
Gross obesity
Item
subject is grossly obese
boolean
C0857116 (UMLS CUI [1])
Operative procedure on knee | Arthroscopy
Item
subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.
boolean
C0187769 (UMLS CUI [1])
C0003904 (UMLS CUI [2])
Osteotomy
Item
subject has a history of osteotomies.
boolean
C0029468 (UMLS CUI [1])
NSAIDs Discontinue Unwilling | Acetaminophen Discontinue Unwilling | Treatment Illicit Discontinue Unwilling
Item
subject is not willing to discontinue the use of nsaids, acetaminophen or other prohibited treatments
boolean
C0003211 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0000970 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0332266 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
Opioids Osteoarthritis Pain
Item
subject used opioids for oa pain within 1 month
boolean
C0242402 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])