ID

31283

Description

Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip; ODM derived from: https://clinicaltrials.gov/show/NCT00864097

Link

https://clinicaltrials.gov/show/NCT00864097

Keywords

Versions (1)
  1. 8/7/18 8/7/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 7, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00864097

English

Eligibility Osteoarthritis NCT00864097

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
osteoarthritis of the knee or hip according to acr criteria with kellgren-lawrence x-ray grade equal to, or greater than, 2.
Description

Knee Osteoarthritis Kellgren-Lawrence score X-ray | Osteoarthritis of hip Kellgren-Lawrence score X-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3177117
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C0029410
UMLS CUI [2,2]
C3177117
UMLS CUI [2,3]
C0034571
patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen.
Description

Oral Diclofenac U/day Stable | Benefit Received By Diclofenac

Data type

boolean

Alias
UMLS CUI [1,1]
C0360479
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0814225
UMLS CUI [2,2]
C1709850
UMLS CUI [2,3]
C0012091
pain and function levels as required by the protocol at screening and baseline.
Description

Pain level Study Protocol | Level of function Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0518087
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0935587
UMLS CUI [2,2]
C2348563
willing to discontinue all non-study pain medications throughout the study except as permitted per protocol.
Description

Analgesics Discontinue Willing | Exception Analgesics Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0002771
UMLS CUI [2,3]
C2348563
willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
bmi greater than 39.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
history of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (ra), joint infections, neuropathic disorders, avascular necrosis, paget's disease or tumors.
Description

Disease Involving Index Knee | Disease Involving Index Hip | Inflammatory joint disease | Crystal Arthropathies | Gout | Pseudogout | Endocrine System Diseases | Arthropathy due to metabolic disorder | Lupus Erythematosus | Rheumatoid Arthritis | Arthropathy associated with infection | Neuropathy | Avascular necrosis | Paget Disease | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C2986546
UMLS CUI [1,4]
C0022742
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C2986546
UMLS CUI [2,4]
C0019552
UMLS CUI [3]
C0683381
UMLS CUI [4]
C0152087
UMLS CUI [5]
C0018099
UMLS CUI [6]
C0033802
UMLS CUI [7]
C0014130
UMLS CUI [8]
C4039860
UMLS CUI [9]
C0409974
UMLS CUI [10]
C0003873
UMLS CUI [11]
C0157749
UMLS CUI [12]
C0442874
UMLS CUI [13]
C3887513
UMLS CUI [14]
C1368019
UMLS CUI [15]
C0006826
fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with oa.
Description

Fibromyalgia | Regional pain syndrome caused by LUMBAR SPINAL CORD COMPRESSION | Regional pain syndrome caused by Cervical cord compression | Radiculopathy | Moderate pain | Severe pain | Interference Evaluation Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1]
C0016053
UMLS CUI [2,1]
C0850603
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0745990
UMLS CUI [3,1]
C0850603
UMLS CUI [3,2]
C0015127
UMLS CUI [3,3]
C0852866
UMLS CUI [4]
C0700594
UMLS CUI [5]
C0278139
UMLS CUI [6]
C0278140
UMLS CUI [7,1]
C0521102
UMLS CUI [7,2]
C1261322
UMLS CUI [7,3]
C0029408
signs and symptoms of clinically significant cardiac disease within 6 months prior to screening.
Description

Signs and Symptoms Heart Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0018799
diagnosis or tia within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
Description

Transient Ischemic Attack | Cerebrovascular accident | Deficits Residual | Study Protocol Completion Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C2987487
UMLS CUI [3,2]
C1609982
UMLS CUI [4,1]
C2348563
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C0332196
history, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
Description

Nervous system disorder | Mental disorders | Sign or Symptom Nervous system disorder | Sign or Symptom Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C0027765
UMLS CUI [4,1]
C3540840
UMLS CUI [4,2]
C0004936
at screening: uncontrolled hypertension, hemoglobin a1c greater than or equal to 10%, alt or ast greater than or equal to 3x upper limit of normal, creatinine exceeding 150 micro-mol/l in men or 133 micro-mol/l in women.
Description

Uncontrolled hypertension | Hemoglobin A1c measurement | Alanine aminotransferase increased | Aspartate aminotransferase increased | Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0079399
patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
Description

Warfarin | Coumadin | Anticoagulant therapy | Lithium therapy

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0699129
UMLS CUI [3]
C0150457
UMLS CUI [4]
C0204592
known hypersensitivity to nsaids (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).
Description

Allergy to nonsteroidal anti-inflammatory agents | Diclofenac allergy | Hypersensitivity Cyclooxygenase Inhibitors | Allergy to Paracetamol

Data type

boolean

Alias
UMLS CUI [1]
C0746949
UMLS CUI [2]
C0570540
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0085387
UMLS CUI [4]
C0570513
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Similar models

Eligibility Osteoarthritis NCT00864097

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Knee Osteoarthritis Kellgren-Lawrence score X-ray | Osteoarthritis of hip Kellgren-Lawrence score X-ray
Item
osteoarthritis of the knee or hip according to acr criteria with kellgren-lawrence x-ray grade equal to, or greater than, 2.
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C0029410 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
Oral Diclofenac U/day Stable | Benefit Received By Diclofenac
Item
patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen.
boolean
C0360479 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0814225 (UMLS CUI [2,1])
C1709850 (UMLS CUI [2,2])
C0012091 (UMLS CUI [2,3])
Pain level Study Protocol | Level of function Study Protocol
Item
pain and function levels as required by the protocol at screening and baseline.
boolean
C0518087 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0935587 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Analgesics Discontinue Willing | Exception Analgesics Study Protocol
Item
willing to discontinue all non-study pain medications throughout the study except as permitted per protocol.
boolean
C0002771 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0002771 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Protocol Compliance
Item
willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnant women.
boolean
C0032961 (UMLS CUI [1])
Body mass index
Item
bmi greater than 39.
boolean
C1305855 (UMLS CUI [1])
Disease Involving Index Knee | Disease Involving Index Hip | Inflammatory joint disease | Crystal Arthropathies | Gout | Pseudogout | Endocrine System Diseases | Arthropathy due to metabolic disorder | Lupus Erythematosus | Rheumatoid Arthritis | Arthropathy associated with infection | Neuropathy | Avascular necrosis | Paget Disease | Malignant Neoplasms
Item
history of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (ra), joint infections, neuropathic disorders, avascular necrosis, paget's disease or tumors.
boolean
C0012634 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0022742 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C2986546 (UMLS CUI [2,3])
C0019552 (UMLS CUI [2,4])
C0683381 (UMLS CUI [3])
C0152087 (UMLS CUI [4])
C0018099 (UMLS CUI [5])
C0033802 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C4039860 (UMLS CUI [8])
C0409974 (UMLS CUI [9])
C0003873 (UMLS CUI [10])
C0157749 (UMLS CUI [11])
C0442874 (UMLS CUI [12])
C3887513 (UMLS CUI [13])
C1368019 (UMLS CUI [14])
C0006826 (UMLS CUI [15])
Fibromyalgia | Regional pain syndrome caused by LUMBAR SPINAL CORD COMPRESSION | Regional pain syndrome caused by Cervical cord compression | Radiculopathy | Moderate pain | Severe pain | Interference Evaluation Osteoarthritis
Item
fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with oa.
boolean
C0016053 (UMLS CUI [1])
C0850603 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0745990 (UMLS CUI [2,3])
C0850603 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0852866 (UMLS CUI [3,3])
C0700594 (UMLS CUI [4])
C0278139 (UMLS CUI [5])
C0278140 (UMLS CUI [6])
C0521102 (UMLS CUI [7,1])
C1261322 (UMLS CUI [7,2])
C0029408 (UMLS CUI [7,3])
Signs and Symptoms Heart Disease
Item
signs and symptoms of clinically significant cardiac disease within 6 months prior to screening.
boolean
C0037088 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Transient Ischemic Attack | Cerebrovascular accident | Deficits Residual | Study Protocol Completion Excluded
Item
diagnosis or tia within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C2987487 (UMLS CUI [3,1])
C1609982 (UMLS CUI [3,2])
C2348563 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
Nervous system disorder | Mental disorders | Sign or Symptom Nervous system disorder | Sign or Symptom Mental disorders
Item
history, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C3540840 (UMLS CUI [3,1])
C0027765 (UMLS CUI [3,2])
C3540840 (UMLS CUI [4,1])
C0004936 (UMLS CUI [4,2])
Uncontrolled hypertension | Hemoglobin A1c measurement | Alanine aminotransferase increased | Aspartate aminotransferase increased | Creatinine measurement, serum | Gender
Item
at screening: uncontrolled hypertension, hemoglobin a1c greater than or equal to 10%, alt or ast greater than or equal to 3x upper limit of normal, creatinine exceeding 150 micro-mol/l in men or 133 micro-mol/l in women.
boolean
C1868885 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0079399 (UMLS CUI [6])
Warfarin | Coumadin | Anticoagulant therapy | Lithium therapy
Item
patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
boolean
C0043031 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
C0150457 (UMLS CUI [3])
C0204592 (UMLS CUI [4])
Allergy to nonsteroidal anti-inflammatory agents | Diclofenac allergy | Hypersensitivity Cyclooxygenase Inhibitors | Allergy to Paracetamol
Item
known hypersensitivity to nsaids (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).
boolean
C0746949 (UMLS CUI [1])
C0570540 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0085387 (UMLS CUI [3,2])
C0570513 (UMLS CUI [4])
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