Age | Gender Childbearing Potential Absent | Gender Sexually active Barrier Contraception | Male sterilization | PLA-695
Item
men or women 50 to 75 years of age. women must be of non-childbearing potential. sexually active men who are not surgically sterile must agree and commit to use of barrier contraception during the study and for at least 12 weeks after the last dose of pla.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0004764 (UMLS CUI [3,3])
C0024559 (UMLS CUI [4])
C3851282 (UMLS CUI [5])
Knee Osteoarthritis idiopathic Duration | Knee pain | Osteophyte Present | Age | crepitus | Morning stiffness Duration
Item
diagnosed with idiopathic oa of the knee for at least 3 months duration in accordance with [1986] american college of rheumatology (acr) clinical and radiographic criteria: knee pain, the presence of osteophytes, and any one of the following: age >50 years, crepitus, or morning stiffness <30 minutes.
boolean
C0409959 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0231749 (UMLS CUI [2])
C1956089 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
C0277964 (UMLS CUI [5])
C0457086 (UMLS CUI [6,1])
C0449238 (UMLS CUI [6,2])
Degenerative polyarthritis Joint Target | Joint Weight Bearing anteroposterior view | Joint Weight Bearing View lateral
Item
radiographic confirmation of oa at the target joint (weight-bearing anteroposterior and lateral views) within 1 year of screening.
boolean
C0029408 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0022417 (UMLS CUI [2,1])
C0085086 (UMLS CUI [2,2])
C3866438 (UMLS CUI [2,3])
C0022417 (UMLS CUI [3,1])
C0085086 (UMLS CUI [3,2])
C1508423 (UMLS CUI [3,3])
Degenerative polyarthritis Treated | Non-Steroidal Anti-Inflammatory Agents Quantity Dose Stable | Cyclooxygenase 2 Inhibitors
Item
must be currently treated for oa with a stable daily dose of 1 nsaid, including cox-2 inhibitors, not exceeding the maximum recommended dose in the product label, and taken as prescribed by the physician, starting at least 4 weeks before the screening visit.
boolean
C0029408 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C1257954 (UMLS CUI [3])
Exclusion Criteria
Item
exclusion criteria: these are some of the main exclusion criteria for the the study. additional exclusion are included in the protocol.
boolean
C0680251 (UMLS CUI [1])
Esophageal bleeding | Gastrointestinal Hemorrhage | Ulcer | Obstruction | Perforation | Pancreatitis | Esophageal bleeding Suspected | Gastrointestinal Hemorrhage Suspected | Ulcer Suspected | Obstruction Suspected | Perforation Suspected | Pancreatitis Suspected
Item
history of or suspected current esophageal or gastrointestinal bleeding, ulcers, obstruction, or perforation, or pancreatitis.
boolean
C0239293 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0041582 (UMLS CUI [3])
C0028778 (UMLS CUI [4])
C0549099 (UMLS CUI [5])
C0030305 (UMLS CUI [6])
C0239293 (UMLS CUI [7,1])
C0750491 (UMLS CUI [7,2])
C0017181 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C0041582 (UMLS CUI [9,1])
C0750491 (UMLS CUI [9,2])
C0028778 (UMLS CUI [10,1])
C0750491 (UMLS CUI [10,2])
C0549099 (UMLS CUI [11,1])
C0750491 (UMLS CUI [11,2])
C0030305 (UMLS CUI [12,1])
C0750491 (UMLS CUI [12,2])
Knee Target radiography Kellgren-Lawrence score
Item
grade 4 severity on the kellgren-lawrence scale on the screening target knee radiograph.
boolean
C0022742 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C3177117 (UMLS CUI [1,4])
Condition Study Subject Participation Status Limited | Condition Preventing Clinical Trial Completion | Cardiovascular Diseases | Hematological Disease | Acute disease of hematopoietic system | Endocrine System Diseases | Respiration Disorders | nervous system disorder | Mental disorders | Metabolic Diseases | Immune System Diseases | Communicable Diseases | Liver diseases | Kidney Diseases
Item
any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory, neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal condition that the investigator considers detrimental to the subject's participating in the study or that may prevent the successful completion of the study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
C0007222 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C1263982 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0035204 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0004936 (UMLS CUI [9])
C0025517 (UMLS CUI [10])
C0021053 (UMLS CUI [11])
C0009450 (UMLS CUI [12])
C0023895 (UMLS CUI [13])
C0022658 (UMLS CUI [14])
Laboratory test result abnormal
Item
any clinically significant laboratory abnormality.
boolean
C0438215 (UMLS CUI [1])