Age
Item
male or female participants between 40 and 80 years of age
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis, Knee Moderate | Osteoarthritis, Knee Moderately severe pain | Osteoarthritis of hip Moderate | Osteoarthritis of hip Moderately severe pain
Item
diagnosis of moderate to moderately-severe osteoarthritis (oa) of either the knee or hip with respect to the following:
boolean
C0409959 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0409959 (UMLS CUI [2,1])
C3843203 (UMLS CUI [2,2])
C0029410 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0029410 (UMLS CUI [4,1])
C3843203 (UMLS CUI [4,2])
Knee pain | Hip pain
Item
pain in one knee/hip over 3 months immediately before screening visit
boolean
C0231749 (UMLS CUI [1])
C0019559 (UMLS CUI [2])
Anti-Inflammatory Agents, Non-Steroidal | Acetaminophen | Analgesics
Item
use of non steroidal anti-inflammatory drugs (nsaids), acetaminophen (paracetamol) or any other analgesic for 3 or more days per week for at least 3 months prior to screening visit
boolean
C0003211 (UMLS CUI [1])
C0000970 (UMLS CUI [2])
C0002771 (UMLS CUI [3])
Prior diagnosis Osteoarthritis, Knee | Prior diagnosis Osteoarthritis of hip
Item
clinical diagnosis of osteoarthritis of knee/hip for minimum 6 month duration prior to screening visit
boolean
C0332132 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
C0332132 (UMLS CUI [2,1])
C0029410 (UMLS CUI [2,2])
Acetaminophen Benefit Therapeutic | Score
Item
therapeutic benefit with acetaminophen use with a score of ≥ 1 on 5-point categorical scale
boolean
C0000970 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C0449820 (UMLS CUI [2])
Degenerative polyarthritis | Kellgren-Lawrence score
Item
radiological evidence of ≥ grade 2 osteoarthritis according to kellgren-lawrence radiographic criteria
boolean
C0029408 (UMLS CUI [1])
C3177117 (UMLS CUI [2])
Western Ontario and McMaster Universities osteoarthritis index | Run-in Period untreated
Item
increased womac pain subscale score of at least 20 % following untreated run-in period
boolean
C3472647 (UMLS CUI [1])
C3274438 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Moderate pain | Moderately severe pain | Run-in Period untreated
Item
moderate to moderately-severe self-reported pain on a 5-point categorical scale following untreated run-in period
boolean
C0278139 (UMLS CUI [1])
C3843203 (UMLS CUI [2])
C3274438 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Acetaminophen Benefit Therapeutic Positive | Degenerative polyarthritis Pain relief
Item
historical self-reported positive therapeutic benefit with paracetamol use for osteoarthritis pain relief
boolean
C0000970 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C1446409 (UMLS CUI [1,4])
C0029408 (UMLS CUI [2,1])
C0451615 (UMLS CUI [2,2])
Operative Surgical Procedures Study Joint | Major injury Study Joint
Item
history of surgery or major trauma to the study joint
boolean
C0543467 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C0332677 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
Sign or Symptom Inflammation | Run-in Period Completion
Item
clinically significant signs or symptoms of inflammation upon completion of run-in period
boolean
C3540840 (UMLS CUI [1,1])
C0021368 (UMLS CUI [1,2])
C3274438 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Indication Analgesic therapy Continuous | Anticoagulants | Psychotropic Drugs | Aspirin | Hypolipidemic Agents | Hydroxymethylglutaryl-CoA Reductase Inhibitors | Therapeutic procedure Interferes with Pain Perception
Item
required ongoing use of analgesic therapy for other indications, anticoagulants, psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class hypolipidemic agents at doses that have not been stabilized, or other treatments know to interfere with pain perception
boolean
C3146298 (UMLS CUI [1,1])
C0412784 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0003280 (UMLS CUI [2])
C0033978 (UMLS CUI [3])
C0004057 (UMLS CUI [4])
C0086440 (UMLS CUI [5])
C0360714 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C3714605 (UMLS CUI [7,3])
Liver diseases | Kidney Diseases | Biliary System Disorder | Gastrointestinal Surgical Procedure
Item
history of hepatic or renal or liver or biliary disease or gastrointestinal surgery
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C3275124 (UMLS CUI [4])
C0524722 (UMLS CUI [5])
Alanine aminotransferase measurement | Serum total bilirubin measurement | Bilirubin, direct measurement | Bilirubin Fractionated | Bilirubin Isolated
Item
participants with alanine aminotransferase (alt) >2 times upper limit normal (2xuln) and bilirubin > 1.5 times upper limit normal (1.5xuln) (however, if direct bilirubin is <35% and fractioned, isolated bilirubin >1.5xuln is acceptable)
boolean
C0201836 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201916 (UMLS CUI [3])
C0005437 (UMLS CUI [4,1])
C1979893 (UMLS CUI [4,2])
C0005437 (UMLS CUI [5,1])
C0205409 (UMLS CUI [5,2])
Arthritis Other | Fibromyalgia | Collagen-vascular disease | Secondary osteoarthritis Study Joint | Chronic pain
Item
other arthritis type, fibromyalgia or collagen vascular disease or secondary oa of study joint or chronic pain condition
boolean
C0003864 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0016053 (UMLS CUI [2])
C0262428 (UMLS CUI [3])
C2732281 (UMLS CUI [4,1])
C0008972 (UMLS CUI [4,2])
C0022417 (UMLS CUI [4,3])
C0150055 (UMLS CUI [5])