Age | Unilateral primary osteoarthritis of knee
Item
patient is between 40 and 85 years of age, patient has primary oa in a single knee (target knee) confirmed by american college of rheumatology criteria.
boolean
C0001779 (UMLS CUI [1])
C2893932 (UMLS CUI [2])
Anti-Inflammatory Agents, Non-Steroidal | Analgesics
Item
for patients taking non-steroidal anti-inflammatory drugs (nsaids) or other analgesics at the time of the screening visit,
boolean
C0003211 (UMLS CUI [1])
C0002771 (UMLS CUI [2])
Visual Analog Pain Scale Range Acceptable
Item
patient has visual analog scale (vas) pain scores with acceptable ranges as determined by the investigator during screening
boolean
C0042815 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
Exception Osteoarthritis | Patient Healthy
Item
except for oa, patient is judged by the investigator to be medically healthy and able to participate in the study.
boolean
C1705847 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C3898900 (UMLS CUI [2,2])
Inclusion criteria Additional
Item
other criteria apply, please contact the investigator for additional information
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Arthritis of knee Secondary | Arthritis of knee inflammatory | Psoriasis | Rheumatoid Arthritis | Gout | Bone Disease Primary | Trauma
Item
patient has secondary or inflammatory arthritis of the knee such as psoriasis, rheumatoid arthritis (ra), gout, other primary bone disease, or acute trauma.
boolean
C0240111 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0240111 (UMLS CUI [2,1])
C0333348 (UMLS CUI [2,2])
C0033860 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
C0018099 (UMLS CUI [5])
C0005940 (UMLS CUI [6,1])
C0205225 (UMLS CUI [6,2])
C3714660 (UMLS CUI [7])
Chondrocalcinosis Symptomatic
Item
patient has symptomatic chondrocalcinosis
boolean
C0221621 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Fibromyalgia
Item
patient has a history of fibromyalgia.
boolean
C0016053 (UMLS CUI [1])
Condition painful | Disabling condition | Interference Assessment Pain scoring
Item
patient has any painful or disabling conditions that in the opinion of the investigator may confound assessment of pain scoring.
boolean
C0348080 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C4061999 (UMLS CUI [2])
C0521102 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C0582148 (UMLS CUI [3,3])
Heart Disease Uncontrolled At risk Patient | Kidney Disease Uncontrolled At risk Patient | Liver disease Uncontrolled At risk Patient | Systemic disease Uncontrolled At risk Patient
Item
patient has uncontrolled cardiac, renal, hepatic or other systemic disorders that in the opinion of the investigator may jeopardize the patient.
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,4])
C0022658 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0030705 (UMLS CUI [2,4])
C0023895 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0030705 (UMLS CUI [3,4])
C0442893 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0030705 (UMLS CUI [4,4])
Edema Target Knee | Dermatologic disorders Target Knee | Pressure Ulcer | Exanthema | Ulcer
Item
patient has significant edema or skin disorder (including sores, rashes, or ulcers) at the target knee and surrounding area.
boolean
C0013604 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0037274 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
C0011127 (UMLS CUI [3])
C0015230 (UMLS CUI [4])
C0041582 (UMLS CUI [5])
Total Knee Replacement Leg Either | Partial Knee Replacement Leg Either
Item
patient has a history of total or partial knee replacement in either leg.
boolean
C0086511 (UMLS CUI [1,1])
C0023216 (UMLS CUI [1,2])
C3844638 (UMLS CUI [1,3])
C0864243 (UMLS CUI [2,1])
C0023216 (UMLS CUI [2,2])
C3844638 (UMLS CUI [2,3])
KNEE SURGERY RECONSTRUCTIVE Target Knee | Arthroscopy Target Knee
Item
patient had a major reconstructive knee surgery or arthroscopy of the target knee within 6 months before the screening visit.
boolean
C0745580 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0003904 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
Opioids Discontinue Unable | Opioids Discontinue Unwilling | Analgesics Discontinue Unable | Analgesics Discontinue Unwilling | Control Osteoarthritis Pain
Item
patient is unable or unwilling to discontinue opioid and/or other prescription analgesics for control of oa pain.
boolean
C0242402 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0242402 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0002771 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0002771 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C0243148 (UMLS CUI [5,1])
C0029408 (UMLS CUI [5,2])
C0030193 (UMLS CUI [5,3])
Intolerance to Investigational New Drugs | Intolerance to Investigational New Drug Excipient | Intolerance to Acetaminophen
Item
patient is intolerant to study drug, its excipients, and/or acetaminophen.
boolean
C1744706 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C1744706 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
Non-Prescription Drugs Oral | Glucosamine | Chondroitin Sulfates | Exception Therapy Stable
Item
patient uses any over the counter oral medications such as glucosamine or chondroitin sulfate products, unless the patient has been receiving the medication for ≥3 months at the time of the screening visit and maintains the medication as stable therapy for the duration of the study.
boolean
C0013231 (UMLS CUI [1,1])
C1272919 (UMLS CUI [1,2])
C0017718 (UMLS CUI [2])
C0008466 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Exclusion Criteria Additional
Item
other criteria apply, please contact the investigator for additional information
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])