ID

22272

Beschrijving

A Study of the Efficacy and Safety of EUFLEXXA™ for Treatment of Painful Osteoarthritis of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00379236

Link

https://clinicaltrials.gov/show/NCT00379236

Trefwoorden

Versies (1)
  1. 28-05-17 28-05-17 -
Geüploaded op

28 mei 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT00379236

Engels

Eligibility Osteoarthritis, Knee NCT00379236

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. chronic oa of target knee confirmed by acr criteria
Beschrijving

Knee Osteoarthritis chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0205191
2. pain due to oa in target knee present for at least 6 months:
Beschrijving

Pain Due to Knee Osteoarthritis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0409959
• moderate to severe pain score of 41 mm to 90 mm recorded on a 100 mm vas immediately following a 50-foot walk
Beschrijving

Pain Following Walking Visual Analog Pain Scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0080331
UMLS CUI [1,4]
C0042815
3. a bilateral standing ap x-ray confirming oa of the target knee—obtained within a 6-month period prior to the screening visit—and a grade of 2 or 3 according to the kellgren and lawrence grading scale
Beschrijving

Knee Osteoarthritis Radiography Anterior-Posterior Standing Bilateral | Knee Osteoarthritis Kellgren-Lawrence score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0034571
UMLS CUI [1,3]
C1999039
UMLS CUI [1,4]
C0231472
UMLS CUI [1,5]
C0238767
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C3177117
4. ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
Beschrijving

Acetaminophen | Investigational New Drugs | Analgesics

Datatype

boolean

Alias
UMLS CUI [1]
C0000970
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0002771
the acetaminophen dose must not exceed 4 grams/day (4000 mg)
Beschrijving

Acetaminophen Dosage U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0000970
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
if subject has known chronic liver disease, the maximum dose of acetaminophen must not exceed 2 grams/day (2000 mg)
Beschrijving

Chronic liver disease | Acetaminophen Dose Maximum U/day

Datatype

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0806909
UMLS CUI [2,4]
C0456683
the subject must be willing and able to discontinue acetaminophen at least 24 hours prior to all study-specific visits
Beschrijving

Acetaminophen Discontinue Willing | Acetaminophen Discontinue Able

Datatype

boolean

Alias
UMLS CUI [1,1]
C0000970
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0085732
the study specific acetaminophen provided will only be used for knee pain.
Beschrijving

Acetaminophen | Knee pain

Datatype

boolean

Alias
UMLS CUI [1]
C0000970
UMLS CUI [2]
C0231749
5. ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs).
Beschrijving

Visual Analog Pain Scale Evaluation | Activities Perform Ability | Able to walk on flat surfaces Distance | Able to walk up stairs | Able to walk down stairs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042815
UMLS CUI [1,2]
C1261322
UMLS CUI [2,1]
C0441655
UMLS CUI [2,2]
C0884358
UMLS CUI [2,3]
C0085732
UMLS CUI [3,1]
C0560049
UMLS CUI [3,2]
C0012751
UMLS CUI [4]
C0560077
UMLS CUI [5]
C0560081
6. willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions
Beschrijving

Questionnaires Completion Able | Questionnaires Completion Willing | Comprehension Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C2348563
7. signed study-specific subject informed consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any major injury (including sports injuries) to the target knee within the 12 months prior to the screening visit
Beschrijving

Major injury Target Knee | Sports Injuries Target Knee

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332677
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
UMLS CUI [2,1]
C0004161
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0022742
2. any surgery to the target knee within the 12 months prior to the screening visit, or surgery to the contralateral knee or other weight-bearing joint if it will interfere with knee assessments
Beschrijving

Operative Surgical Procedures Target Knee | Operative Surgical Procedures Knee Contralateral | Operative Surgical Procedures Joint Weight Bearing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C0441988
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0022417
UMLS CUI [3,3]
C0085086
3. prior articular procedures, such as transplants or ligament reconstruction to the target knee
Beschrijving

Procedure on articular system | Transplantation Target Knee | Ligament reconstruction Target Knee

Datatype

boolean

Alias
UMLS CUI [1]
C1292860
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0022742
UMLS CUI [3,1]
C0547071
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0022742
4. inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis
Beschrijving

Inflammatory arthropathy | Rheumatoid Arthritis | Arthropathy | Lupus Erythematosus, Systemic | Arthritis, Psoriatic

Datatype

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0022408
UMLS CUI [4]
C0024141
UMLS CUI [5]
C0003872
5. gout or calcium pyrophosphate (pseudogout) diseases that have flared within the previous 6 months prior to the screening visit
Beschrijving

Gout | Calcium pyrophosphate deposition disease | Pseudogout

Datatype

boolean

Alias
UMLS CUI [1]
C0018099
UMLS CUI [2]
C0553730
UMLS CUI [3]
C0033802
6. x-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee
Beschrijving

Radiography | Fracture | Bone Density Loss Severe | Avascular necrosis | Target Knee Deformity of bone Severe | Target Knee Joint Deformity Severe

Datatype

boolean

Alias
UMLS CUI [1]
C0034571
UMLS CUI [2]
C0016658
UMLS CUI [3,1]
C0005938
UMLS CUI [3,2]
C1517945
UMLS CUI [3,3]
C0205082
UMLS CUI [4]
C3887513
UMLS CUI [5,1]
C1521840
UMLS CUI [5,2]
C0022742
UMLS CUI [5,3]
C0410719
UMLS CUI [5,4]
C0205082
UMLS CUI [6,1]
C1521840
UMLS CUI [6,2]
C0022742
UMLS CUI [6,3]
C0022417
UMLS CUI [6,4]
C0302142
UMLS CUI [6,5]
C0205082
7. osteonecrosis of either knee
Beschrijving

Bone necrosis Knee

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029445
UMLS CUI [1,2]
C0022742
8. fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
Beschrijving

Fibromyalgia | Pes anserinus Bursitis | Lumbar radiculopathy | Neurogenic claudication | Claudication Vascular

Datatype

boolean

Alias
UMLS CUI [1]
C0016053
UMLS CUI [2,1]
C1283556
UMLS CUI [2,2]
C0006444
UMLS CUI [3]
C1263855
UMLS CUI [4]
C0580173
UMLS CUI [5,1]
C1456822
UMLS CUI [5,2]
C1801960
9. significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in the target knee
Beschrijving

Anterior knee pain | Patellofemoral Pain Syndrome Isolated Target Knee | chondromalacia knee

Datatype

boolean

Alias
UMLS CUI [1]
C0409326
UMLS CUI [2,1]
C0877149
UMLS CUI [2,2]
C0205409
UMLS CUI [2,3]
C1521840
UMLS CUI [2,4]
C0022742
UMLS CUI [3]
C2902706
10. significant target knee joint infection or skin disorder/infection within the previous 6 months prior to study enrollment
Beschrijving

Knee joint Target Communicable Disease | Knee joint Target Dermatologic disorder | Knee joint Target Infectious Skin Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022745
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0009450
UMLS CUI [2,1]
C0022745
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0037274
UMLS CUI [3,1]
C0022745
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0037278
11. symptomatic oa of the hips, spine, or ankle, if it would interfere with the evaluation of the target knee
Beschrijving

Osteoarthritis of hip Symptomatic | Osteoarthritis of spine Symptomatic | Osteoarthritis of ankle Symptomatic | Disease Interferes with Evaluation Target Knee

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029410
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C2350242
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0409931
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C1521840
UMLS CUI [4,5]
C0022742
12. known hypersensitivity to acetaminophen, euflexxa™, or phosphate buffered saline solution
Beschrijving

Hypersensitivity Acetaminophen | Hypersensitivity Euflexxa | Hypersensitivity Saline Solution Buffered phosphate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0000970
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1637315
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0036082
UMLS CUI [3,3]
C0991865
13. 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
Beschrijving

Childbearing Potential Contraceptive methods Unwilling | Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0032992
14. recurrent medical history of severe allergic or immune-mediated reactions or other immune disorders
Beschrijving

Recurrent disease | Allergic Reaction Severe | Nonspecific immune reaction Severe | Immune System Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0301874
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0021053
15. vascular insufficiency of lower limbs or peripheral neuropathy severe enough to interfere with the study evaluation
Beschrijving

Vascular insufficiency Lower Extremity | Peripheral Neuropathy Severe Interferes with Clinical Trial Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232352
UMLS CUI [1,2]
C0023216
UMLS CUI [2,1]
C0031117
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0008976
UMLS CUI [2,5]
C1261322
16. 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)
Beschrijving

cancer treatment | Basal cell carcinoma | Squamous cell carcinoma of skin

Datatype

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
17. active liver disease based on liver profile of ast, alt, and conjugated bilirubin >2 times the upper limit of normal
Beschrijving

Liver diseases | Aspartate aminotransferase increased | Alanine aminotransferase increased | Bilirubin conjugated increased

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0855625
18. renal insufficiency based on serum creatinine >2.0 mg/dl
Beschrijving

Renal Insufficiency | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
19. any clinically significant laboratory value based on clinical history that the investigator feels may affect the study evaluation
Beschrijving

Laboratory Results Affecting Evaluation Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0008976
20. any intercurrent chronic disease or condition that may interfere with the completion of the 6-month (or 12-month) follow-up of the study, such as liver disease, severe coronary disease, drug abuse, disordered mental state, or other clinically significant condition
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C3274571
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
UMLS CUI [3]
C0023895
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0013146
UMLS CUI [6]
C0004936
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C2826293
21. current alcoholism, and/or any known current addiction to pain medications
Beschrijving

Alcoholic Intoxication, Chronic | Analgesics Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0002771
UMLS CUI [2,2]
C0439857
22. any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
Beschrijving

Finding At risk Patient Health | Finding Impact Clinical Trial | Finding Affecting Clinical Trial Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C0018684
UMLS CUI [2,1]
C0243095
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C0243095
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0008976
UMLS CUI [3,4]
C0205197
23. any psychiatric illness that would prevent comprehension of the details and nature of the study
Beschrijving

Mental disorders Preventing Comprehension Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
24. participation in any experimental drug or device study within the 6 months prior to the screening visit
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Osteoarthritis, Knee NCT00379236

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Knee Osteoarthritis chronic
Item
1. chronic oa of target knee confirmed by acr criteria
boolean
C0409959 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Pain Due to Knee Osteoarthritis
Item
2. pain due to oa in target knee present for at least 6 months:
boolean
C0030193 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,3])
Pain Following Walking Visual Analog Pain Scale
Item
• moderate to severe pain score of 41 mm to 90 mm recorded on a 100 mm vas immediately following a 50-foot walk
boolean
C0030193 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
C0042815 (UMLS CUI [1,4])
Knee Osteoarthritis Radiography Anterior-Posterior Standing Bilateral | Knee Osteoarthritis Kellgren-Lawrence score
Item
3. a bilateral standing ap x-ray confirming oa of the target knee—obtained within a 6-month period prior to the screening visit—and a grade of 2 or 3 according to the kellgren and lawrence grading scale
boolean
C0409959 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1999039 (UMLS CUI [1,3])
C0231472 (UMLS CUI [1,4])
C0238767 (UMLS CUI [1,5])
C0409959 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
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 | Knee pain
Item
the study specific acetaminophen provided will only be used for knee pain.
boolean
C0000970 (UMLS CUI [1])
C0231749 (UMLS CUI [2])
Visual Analog Pain Scale Evaluation | Activities Perform Ability | Able to walk on flat surfaces Distance | Able to walk up stairs | Able to walk down stairs
Item
5. ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs).
boolean
C0042815 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0441655 (UMLS CUI [2,1])
C0884358 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C0560049 (UMLS CUI [3,1])
C0012751 (UMLS CUI [3,2])
C0560077 (UMLS CUI [4])
C0560081 (UMLS CUI [5])
Questionnaires Completion Able | Questionnaires Completion Willing | Comprehension Study Protocol
Item
6. 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
7. signed study-specific subject informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Major injury Target Knee | Sports Injuries Target Knee
Item
1. any major injury (including sports injuries) to the target knee within the 12 months prior to the screening visit
boolean
C0332677 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0004161 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
Operative Surgical Procedures Target Knee | Operative Surgical Procedures Knee Contralateral | Operative Surgical Procedures Joint Weight Bearing
Item
2. any surgery to the target knee within the 12 months prior to the screening visit, or surgery to the contralateral knee or other weight-bearing joint if it will interfere with knee assessments
boolean
C0543467 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0441988 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0022417 (UMLS CUI [3,2])
C0085086 (UMLS CUI [3,3])
Procedure on articular system | Transplantation Target Knee | Ligament reconstruction Target Knee
Item
3. prior articular procedures, such as transplants or ligament reconstruction to the target knee
boolean
C1292860 (UMLS CUI [1])
C0040732 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
C0547071 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0022742 (UMLS CUI [3,3])
Inflammatory arthropathy | Rheumatoid Arthritis | Arthropathy | Lupus Erythematosus, Systemic | Arthritis, Psoriatic
Item
4. inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis
boolean
C0003864 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0022408 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0003872 (UMLS CUI [5])
Gout | Calcium pyrophosphate deposition disease | Pseudogout
Item
5. gout or calcium pyrophosphate (pseudogout) diseases that have flared within the previous 6 months prior to the screening visit
boolean
C0018099 (UMLS CUI [1])
C0553730 (UMLS CUI [2])
C0033802 (UMLS CUI [3])
Radiography | Fracture | Bone Density Loss Severe | Avascular necrosis | Target Knee Deformity of bone Severe | Target Knee Joint Deformity Severe
Item
6. x-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee
boolean
C0034571 (UMLS CUI [1])
C0016658 (UMLS CUI [2])
C0005938 (UMLS CUI [3,1])
C1517945 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C3887513 (UMLS CUI [4])
C1521840 (UMLS CUI [5,1])
C0022742 (UMLS CUI [5,2])
C0410719 (UMLS CUI [5,3])
C0205082 (UMLS CUI [5,4])
C1521840 (UMLS CUI [6,1])
C0022742 (UMLS CUI [6,2])
C0022417 (UMLS CUI [6,3])
C0302142 (UMLS CUI [6,4])
C0205082 (UMLS CUI [6,5])
Bone necrosis Knee
Item
7. osteonecrosis of either knee
boolean
C0029445 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
Fibromyalgia | Pes anserinus Bursitis | Lumbar radiculopathy | Neurogenic claudication | Claudication Vascular
Item
8. fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
boolean
C0016053 (UMLS CUI [1])
C1283556 (UMLS CUI [2,1])
C0006444 (UMLS CUI [2,2])
C1263855 (UMLS CUI [3])
C0580173 (UMLS CUI [4])
C1456822 (UMLS CUI [5,1])
C1801960 (UMLS CUI [5,2])
Anterior knee pain | Patellofemoral Pain Syndrome Isolated Target Knee | chondromalacia knee
Item
9. significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in the target knee
boolean
C0409326 (UMLS CUI [1])
C0877149 (UMLS CUI [2,1])
C0205409 (UMLS CUI [2,2])
C1521840 (UMLS CUI [2,3])
C0022742 (UMLS CUI [2,4])
C2902706 (UMLS CUI [3])
Knee joint Target Communicable Disease | Knee joint Target Dermatologic disorder | Knee joint Target Infectious Skin Disease
Item
10. significant target knee joint infection or skin disorder/infection within the previous 6 months prior to study enrollment
boolean
C0022745 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0022745 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0037274 (UMLS CUI [2,3])
C0022745 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0037278 (UMLS CUI [3,3])
Osteoarthritis of hip Symptomatic | Osteoarthritis of spine Symptomatic | Osteoarthritis of ankle Symptomatic | Disease Interferes with Evaluation Target Knee
Item
11. symptomatic oa of the hips, spine, or ankle, if it would interfere with the evaluation of the target knee
boolean
C0029410 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2350242 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0409931 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C1521840 (UMLS CUI [4,4])
C0022742 (UMLS CUI [4,5])
Hypersensitivity Acetaminophen | Hypersensitivity Euflexxa | Hypersensitivity Saline Solution Buffered phosphate
Item
12. 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
13. 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
14. 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])
Vascular insufficiency Lower Extremity | Peripheral Neuropathy Severe Interferes with Clinical Trial Evaluation
Item
15. vascular insufficiency of lower limbs or peripheral neuropathy severe enough to interfere with the study evaluation
boolean
C0232352 (UMLS CUI [1,1])
C0023216 (UMLS CUI [1,2])
C0031117 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C1261322 (UMLS CUI [2,5])
cancer treatment | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
16. 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
17. 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
18. 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
19. 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
20. any intercurrent chronic disease or condition that may interfere with the completion of the 6-month (or 12-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
21. 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 Patient Health | Finding Impact Clinical Trial | Finding Affecting Clinical Trial Completion
Item
22. any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
boolean
C0243095 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (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 disorders Preventing Comprehension Study Protocol
Item
23. 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 New Drugs | Investigational Medical Device
Item
24. participation in any experimental drug or device study within the 6 months prior to the screening visit
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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