Osteoarthritis of the hand Duration
Item
the clinical diagnosis of osteoarthritis of the hand, of at least 6 months duration.
boolean
C0263746 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Pain Thumb joint Due to Osteoarthritis | Joint Pain Average Numeric Pain Scale
Item
pain around one of the thumb joints due to osteoarthritis. the patient must report the average pain in this joint, in the week prior to screening, as at least 5 on an 11-point numerical pain rating scale at the time of screening.
boolean
C0030193 (UMLS CUI [1,1])
C0459473 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0029408 (UMLS CUI [1,4])
C4085641 (UMLS CUI [2,1])
C1510992 (UMLS CUI [2,2])
C1518471 (UMLS CUI [2,3])
Pain pressure Thumb joint | Pain pressure Threshold
Item
the patient must demonstrate pressure pain at a thumb joint by reporting a pressure pain threshold lower than 300 kpa.
boolean
C3647129 (UMLS CUI [1,1])
C0459473 (UMLS CUI [1,2])
C3647129 (UMLS CUI [2,1])
C0449864 (UMLS CUI [2,2])
Pregnancy Urine pregnancy test | Breast Feeding
Item
pregnant (as judged by a urine pregnancy test) or lactating female.
boolean
C0032961 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
Severe pain | Assessment Limited Osteoarthritis Pain
Item
other severe pain which may impair the assessment of the pain due to osteoarthritis.
boolean
C0278140 (UMLS CUI [1])
C1516048 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0029408 (UMLS CUI [2,3])
C0030193 (UMLS CUI [2,4])
Dermatologic disorder Thumb joint | Pain Threshold Testing | Interference Assessment Pain Threshold
Item
skin condition over the thumb joint, which will be used for pain threshold testing, that could interfere with the assessment of pain thresholds.
boolean
C0037274 (UMLS CUI [1,1])
C0459473 (UMLS CUI [1,2])
C0162703 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C0162703 (UMLS CUI [3,3])
OXYCODONE ALLERGY | Allergy to nonsteroidal anti-inflammatory agents | Allergy to tramadol
Item
known hypersensitivity to oxycodone, nsaids or tramadol.
boolean
C0747116 (UMLS CUI [1])
C0746949 (UMLS CUI [2])
C3472517 (UMLS CUI [3])
Medical contraindication NSAIDs | Medical contraindication Oxycodone | Medical contraindication Tramadol | Pharmaceutical Preparations Contraindicated Investigational New Drugs
Item
patients in whom nsaids, oxycodone or tramadol are contraindicated, or patients taking any concurrent medications which are contraindicated with any of the study medications .
boolean
C1301624 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0030049 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0040610 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C1444657 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
Renal clearance Predicted by Cockcroft-Gault formula
Item
an estimated renal clearance of less than 30 ml/min based on the cockcroft gault equation.
boolean
C0232813 (UMLS CUI [1,1])
C4544894 (UMLS CUI [1,2])
Illicit medication use | Washout Period Appropriate Absent
Item
use of prohibited medications as listed below, in the absence of appropriate washout periods:
boolean
C0281875 (UMLS CUI [1])
C1710661 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intramuscular
Item
oral or intramuscular corticosteroids within 4 weeks prior to screening.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
Monoamine Oxidase Inhibitors
Item
monoamine oxidase inhibitors within 2 weeks of screening.
boolean
C0026457 (UMLS CUI [1])
Analgesics | Exception Aspirin | Exception Acetaminophen | Aspirin Cardiovascular event prophylaxis allowed
Item
analgesic agents, other than aspirin, or acetaminophen within 1 week prior to screening. (aspirin use less than or equal to 325 mg per day for cardiovascular prophylaxis is permitted)
boolean
C0002771 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
C0004057 (UMLS CUI [4,1])
C1610618 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Acetaminophen U/day allowed
Item
acetaminophen up to 4 g/day may be used, provided it is not used in the 24 hours prior to any assessment of pain thresholds.
boolean
C0000970 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Intraarticular injection of steroids Index Joint | Intraarticular injection of steroids Joint
Item
intra-articular steroid injections into the study joint within 12 weeks, or to any other joint within 4 weeks, prior to screening.
boolean
C2064783 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C2064783 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
Chronic constipation | Condition At risk Respiratory Depression
Item
history of chronic constipation, or of any condition which, in the opinion of the investigator, may put the patient at increased risk of respiratory depression.
boolean
C0401149 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0235063 (UMLS CUI [2,3])