Age
Item
1. men or women ≥40 years of age
boolean
C0001779 (UMLS CUI [1])
Pain Frequency Pain score | Idiopathic osteoarthritis Carpometacarpal joint First
Item
2. pain due to primary oa of the first cmc joint present for at least half the days of the previous month and a mean combined pain score ≥ 30 mm out of 100 mm of the 5 pain questions on the auscan index pain subscale (see appendix 1)
boolean
C0030193 (UMLS CUI [1,1])
C0376249 (UMLS CUI [1,2])
C0582148 (UMLS CUI [1,3])
C0409952 (UMLS CUI [2,1])
C1321524 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
Degenerative polyarthritis Carpometacarpal joint First Thumb Target | Degenerative polyarthritis Kellgren-Lawrence score Radiography
Item
3. a series of x-rays confirming oa of the first cmc joint of the target thumb obtained at screening with a stage of 2, 3, or 4 according to grading scale in appendix 3.
boolean
C0029408 (UMLS CUI [1,1])
C1321524 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0040067 (UMLS CUI [1,4])
C1521840 (UMLS CUI [1,5])
C0029408 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
Acetaminophen | Investigational New Drugs | Analgesics
Item
4. ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
boolean
C0000970 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0002771 (UMLS CUI [3])
Acetaminophen Dosage U/day
Item
the acetaminophen dose must not exceed 4 grams/day (4000 mg)
boolean
C0000970 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Chronic liver disease | Acetaminophen Dose Maximum U/day
Item
if subject has known chronic liver disease, the maximum dose of acetaminophen must not exceed 2 grams/day (2000 mg)
boolean
C0341439 (UMLS CUI [1])
C0000970 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Acetaminophen Discontinue Willing | Acetaminophen Discontinue Able
Item
the subject must be willing and able to discontinue acetaminophen at least 24 hours prior to all study-specific visits
boolean
C0000970 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0000970 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Acetaminophen | Pain in thumb | Arthralgia
Item
the study specific acetaminophen provided will only be used for thumb/joint pain.
boolean
C0000970 (UMLS CUI [1])
C0241394 (UMLS CUI [2])
C0003862 (UMLS CUI [3])
Questionnaires Completion Able | Questionnaires Completion Willing | Comprehension Study Protocol
Item
5. willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0162340 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
Informed Consent
Item
6. signed study-specific subject informed consent form
boolean
C0021430 (UMLS CUI [1])
Thumb Target Major injury
Item
1. any major injury to the target thumb within the 6 months prior to the screening visit
boolean
C0040067 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0332677 (UMLS CUI [1,3])
Carpal Tunnel Syndrome | De Quervain Disease | Trigger Finger Disorder | Hand Target Synovial Cyst | Atrophy Extreme | Two point discrimination distance
Item
2. anyone having carpal tunnel syndrome (cts), dequervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand only if there is evidence of extreme atrophy and two-point average discrimination is greater than 10-mm, or if the pain from these conditions renders the subject unable to objectively assess oa pain in the target hand
boolean
C0007286 (UMLS CUI [1])
C0149870 (UMLS CUI [2])
C0158328 (UMLS CUI [3])
C0018563 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C0085648 (UMLS CUI [4,3])
C0333641 (UMLS CUI [5,1])
C0205403 (UMLS CUI [5,2])
C0576681 (UMLS CUI [6])
Joint Target Operative Surgical Procedures
Item
3. any surgery to the target joint within the 12 months prior to the screening visit
boolean
C0022417 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Self-Help Devices Use Regular | Cane user | Crutches
Item
4. regular use of assistive devices such as a cane or crutch or a cts brace
boolean
C0036605 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0920240 (UMLS CUI [2])
C0010397 (UMLS CUI [3])
Rheumatism | Rheumatoid Arthritis | Arthropathy | Lupus Erythematosus, Systemic | Arthritis, Psoriatic
Item
5. concomitant rheumatic disease (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis)
boolean
C0035435 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0022408 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0003872 (UMLS CUI [5])
Joint Target Chondrocalcinosis
Item
6. history of chondrocalcinosis in the target joint
boolean
C0022417 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0221621 (UMLS CUI [1,3])
Joint Gout Exacerbated
Item
7. gout exacerbation in any joint in the past 6 months
boolean
C0022417 (UMLS CUI [1,1])
C0018099 (UMLS CUI [1,2])
C1444749 (UMLS CUI [1,3])
Radiography | Fracture | Bone Density Loss Severe | Joint Target Deformity of bone Severe | Target Joint Deformity Severe
Item
8. x-ray findings of acute fractures, severe loss of bone density, and/or severe bone or joint deformity in the target joint
boolean
C0034571 (UMLS CUI [1])
C0016658 (UMLS CUI [2])
C0005938 (UMLS CUI [3,1])
C1517945 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C0022417 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C0410719 (UMLS CUI [4,3])
C0205082 (UMLS CUI [4,4])
C1521840 (UMLS CUI [5,1])
C0022417 (UMLS CUI [5,2])
C0302142 (UMLS CUI [5,3])
C0205082 (UMLS CUI [5,4])
Joint Target Communicable Disease | Joint Target Dermatologic disorder | Joint Target Infectious Skin Disease
Item
9. significant target joint infection or skin disorder/infection within the 3 months prior to study enrollment
boolean
C0022417 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0022417 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0037274 (UMLS CUI [2,3])
C0022417 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0037278 (UMLS CUI [3,3])
Hypersensitivity Acetaminophen | Hypersensitivity Euflexxa | Hypersensitivity Saline Solution Buffered phosphate
Item
10. known hypersensitivity to acetaminophen, euflexxa™, or phosphate buffered saline solution
boolean
C0020517 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1637315 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0036082 (UMLS CUI [3,2])
C0991865 (UMLS CUI [3,3])
Childbearing Potential Contraceptive methods Unwilling | Pregnancy | Breast Feeding | Pregnancy, Planned
Item
11. women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032992 (UMLS CUI [4])
Recurrent disease | Allergic Reaction Severe | Nonspecific immune reaction Severe | Immune System Diseases
Item
12. recurrent medical history of severe allergic or immune-mediated reactions or other immune disorders
boolean
C0277556 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0301874 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0021053 (UMLS CUI [4])
cancer treatment | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
13. current treatment or treatment within the previous 2 years prior to the screening visit for any malignancy unless specific written permission is provided by the sponsor (excluding basal cell or squamous cell carcinoma of the skin)
boolean
C0920425 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
Liver diseases | Aspartate aminotransferase increased | Alanine aminotransferase increased | Bilirubin conjugated increased
Item
14. active liver disease based on liver profile of ast, alt, and conjugated bilirubin >2 times the upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0855625 (UMLS CUI [4])
Renal Insufficiency | Creatinine measurement, serum
Item
15. renal insufficiency based on serum creatinine >2.0 mg/dl
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Laboratory Results Affecting Evaluation Clinical Trial
Item
16. any clinically significant laboratory value based on clinical history that the investigator feels may affect the study evaluation
boolean
C1254595 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Comorbidity chronic Interferes with Clinical Study Follow-up | Condition Interferes with Clinical Study Follow-up | Liver diseases | Coronary Artery Disease Severe | Drug abuse | Mental disorders | Condition Clinical Significance
Item
17. any intercurrent chronic disease or condition that may interfere with the completion of the 6-month follow-up of the study, such as liver disease, severe coronary disease, drug abuse, disordered mental state, or other clinically significant condition
boolean
C0009488 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C3274571 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3])
C1956346 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0013146 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0348080 (UMLS CUI [7,1])
C2826293 (UMLS CUI [7,2])
Alcoholic Intoxication, Chronic | Analgesics Dependence
Item
18. current alcoholism, and/or any known current addiction to pain medications
boolean
C0001973 (UMLS CUI [1])
C0002771 (UMLS CUI [2,1])
C0439857 (UMLS CUI [2,2])
Finding At risk Study Subject Health | Finding Impact Clinical Trial | Finding Affecting Clinical Trial Completion
Item
19. any clinically significant finding that would place the subject at health risk, impact the study, or affect the completion of the study
boolean
C0243095 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0018684 (UMLS CUI [1,4])
C0243095 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0243095 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])
Mental disorder Preventing Comprehension Study Protocol
Item
20. any psychiatric illness that would prevent comprehension of the details and nature of the study
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
21. participation in any experimental device study within 6 months prior to the screening visit, or an experimental drug study within 1 month prior to the screening visit
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])