Knee Osteoarthritis Kellgren-Lawrence score X-ray | Osteoarthritis of hip Kellgren-Lawrence score X-ray
Item
osteoarthritis of the knee or hip according to acr criteria with kellgren-lawrence x-ray grade equal to, or greater than, 2.
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C0029410 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
Oral Diclofenac U/day Stable | Benefit Received By Diclofenac
Item
patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen.
boolean
C0360479 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0814225 (UMLS CUI [2,1])
C1709850 (UMLS CUI [2,2])
C0012091 (UMLS CUI [2,3])
Pain level Study Protocol | Level of function Study Protocol
Item
pain and function levels as required by the protocol at screening and baseline.
boolean
C0518087 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0935587 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Analgesics Discontinue Willing | Exception Analgesics Study Protocol
Item
willing to discontinue all non-study pain medications throughout the study except as permitted per protocol.
boolean
C0002771 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0002771 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Protocol Compliance
Item
willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Pregnancy
Item
pregnant women.
boolean
C0032961 (UMLS CUI [1])
Body mass index
Item
bmi greater than 39.
boolean
C1305855 (UMLS CUI [1])
Disease Involving Index Knee | Disease Involving Index Hip | Inflammatory joint disease | Crystal Arthropathies | Gout | Pseudogout | Endocrine System Diseases | Arthropathy due to metabolic disorder | Lupus Erythematosus | Rheumatoid Arthritis | Arthropathy associated with infection | Neuropathy | Avascular necrosis | Paget Disease | Malignant Neoplasms
Item
history of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (ra), joint infections, neuropathic disorders, avascular necrosis, paget's disease or tumors.
boolean
C0012634 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0022742 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C2986546 (UMLS CUI [2,3])
C0019552 (UMLS CUI [2,4])
C0683381 (UMLS CUI [3])
C0152087 (UMLS CUI [4])
C0018099 (UMLS CUI [5])
C0033802 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C4039860 (UMLS CUI [8])
C0409974 (UMLS CUI [9])
C0003873 (UMLS CUI [10])
C0157749 (UMLS CUI [11])
C0442874 (UMLS CUI [12])
C3887513 (UMLS CUI [13])
C1368019 (UMLS CUI [14])
C0006826 (UMLS CUI [15])
Fibromyalgia | Regional pain syndrome caused by LUMBAR SPINAL CORD COMPRESSION | Regional pain syndrome caused by Cervical cord compression | Radiculopathy | Moderate pain | Severe pain | Interference Evaluation Osteoarthritis
Item
fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with oa.
boolean
C0016053 (UMLS CUI [1])
C0850603 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0745990 (UMLS CUI [2,3])
C0850603 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0852866 (UMLS CUI [3,3])
C0700594 (UMLS CUI [4])
C0278139 (UMLS CUI [5])
C0278140 (UMLS CUI [6])
C0521102 (UMLS CUI [7,1])
C1261322 (UMLS CUI [7,2])
C0029408 (UMLS CUI [7,3])
Signs and Symptoms Heart Disease
Item
signs and symptoms of clinically significant cardiac disease within 6 months prior to screening.
boolean
C0037088 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Transient Ischemic Attack | Cerebrovascular accident | Deficits Residual | Study Protocol Completion Excluded
Item
diagnosis or tia within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C2987487 (UMLS CUI [3,1])
C1609982 (UMLS CUI [3,2])
C2348563 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
Nervous system disorder | Mental disorders | Sign or Symptom Nervous system disorder | Sign or Symptom Mental disorders
Item
history, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C3540840 (UMLS CUI [3,1])
C0027765 (UMLS CUI [3,2])
C3540840 (UMLS CUI [4,1])
C0004936 (UMLS CUI [4,2])
Uncontrolled hypertension | Hemoglobin A1c measurement | Alanine aminotransferase increased | Aspartate aminotransferase increased | Creatinine measurement, serum | Gender
Item
at screening: uncontrolled hypertension, hemoglobin a1c greater than or equal to 10%, alt or ast greater than or equal to 3x upper limit of normal, creatinine exceeding 150 micro-mol/l in men or 133 micro-mol/l in women.
boolean
C1868885 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0079399 (UMLS CUI [6])
Warfarin | Coumadin | Anticoagulant therapy | Lithium therapy
Item
patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
boolean
C0043031 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
C0150457 (UMLS CUI [3])
C0204592 (UMLS CUI [4])
Allergy to nonsteroidal anti-inflammatory agents | Diclofenac allergy | Hypersensitivity Cyclooxygenase Inhibitors | Allergy to Paracetamol
Item
known hypersensitivity to nsaids (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).
boolean
C0746949 (UMLS CUI [1])
C0570540 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0085387 (UMLS CUI [3,2])
C0570513 (UMLS CUI [4])