ID

31253

Description

Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib.; ODM derived from: https://clinicaltrials.gov/show/NCT00484718

Link

https://clinicaltrials.gov/show/NCT00484718

Keywords

Versions (1)
  1. 8/3/18 8/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00484718

English

Eligibility Osteoarthritis NCT00484718

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has been taking an nsaid at least 15 of the past 30 days for index knee pain
Description

NSAID Index Knee Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022742
UMLS CUI [1,4]
C0030193
grades 2 or 3 oa as defined by the kellgren and lawrence grading system of the medial tibiofemoral joint (joint space narrowing in the medial compartment > lateral compartment as assessed by x-ray) using the altman atlas of oa7. this must be documented with a report from an x-ray of the study joint taken either at screening or within 1 year prior to screening
Description

Osteoarthritis Femorotibial joint Medial Kellgren-Lawrence score | Index Joint X-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C1269072
UMLS CUI [1,3]
C0205098
UMLS CUI [1,4]
C3177117
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0022417
UMLS CUI [2,3]
C0034571
subject meets american college of rheumatology (acr) clinical classification criteria for osteoarthritis of the knee, defined by the following: knee pain and at least 3 of the following: oage >50 omorning stiffness <30 minutes ocrepitus on active motion obony tenderness obony enlargement ono palpable warmth of synovium.
Description

Knee Osteoarthritis ACR Criteria Fulfill | Knee pain | Age | Morning stiffness Duration | Joint crepitus | Bone tenderness | Bone enlargement | Joint warmth Synovial Membrane Palpable Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3273747
UMLS CUI [1,3]
C1550543
UMLS CUI [2]
C0231749
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0457086
UMLS CUI [4,2]
C0449238
UMLS CUI [5]
C0231592
UMLS CUI [6]
C0238807
UMLS CUI [7]
C2203582
UMLS CUI [8,1]
C0240095
UMLS CUI [8,2]
C0039099
UMLS CUI [8,3]
C0522499
UMLS CUI [8,4]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a documented history of an allergic reaction (hives, rash, etc.) or a clinically significant intolerance to celecoxib, sulfonamides, aspirin, or opioids including oxycodone
Description

Allergic Reaction | Urticaria | Exanthema | Intolerance to celecoxib | Intolerance to Sulfonamides | Intolerance to Aspirin | Intolerance to Opioids | Intolerance to Oxycodone

Data type

boolean

Alias
UMLS CUI [1]
C1527304
UMLS CUI [2]
C0042109
UMLS CUI [3]
C0015230
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0538927
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0038760
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0004057
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0242402
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0030049
significant pain outside the index knee, including significant hip or back pain that can not be distinguished from oa pain or that interferes with ability to walk. (patients with bilateral knee oa will be allowed into the study. the index knee should be defined as the more painful knee
Description

Pain outside Index Knee | Hip pain Interferes with Ability to walk | Back Pain Interferes with Ability to walk | Osteoarthritis Pain | Bilateral primary osteoarthritis of knee allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0205101
UMLS CUI [1,3]
C2986546
UMLS CUI [1,4]
C0022742
UMLS CUI [2,1]
C0019559
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0559964
UMLS CUI [3,1]
C0004604
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0559964
UMLS CUI [4,1]
C0029408
UMLS CUI [4,2]
C0030193
UMLS CUI [5,1]
C2893930
UMLS CUI [5,2]
C0683607
predominantly patellofemoral knee osteoarthritis in the index knee as assessed by clinical examination
Description

Patellofemoral osteoarthritis Index Knee Clinical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C1542808
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022742
UMLS CUI [1,4]
C1456356
subject who are unable to discontinue all formulations of prior analgesics other than acetaminophen during the washout period of the study, or who are anticipated to be unable to discontinue rescue medication for 24 hours prior to the respective visits. (low dose aspirin may be taken for cardiac prophylaxis
Description

Unable to discontinue Analgesics Formulation | Exception Acetaminophen | Other Coding | Aspirin Low Dose Cardiac prophylaxis allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C1548265
UMLS CUI [1,2]
C0002771
UMLS CUI [1,3]
C0524527
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0000970
UMLS CUI [3]
C3846158
UMLS CUI [4,1]
C2608320
UMLS CUI [4,2]
C1739404
UMLS CUI [4,3]
C0683607
excessive signal knee joint laxity indicative of functional ligamentous deficiency
Description

Knee joint laxity Excessive | Indication Deficiency Ligament Functional

Data type

boolean

Alias
UMLS CUI [1,1]
C0574996
UMLS CUI [1,2]
C0442802
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0011155
UMLS CUI [2,3]
C0023685
UMLS CUI [2,4]
C0205245
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Similar models

Eligibility Osteoarthritis NCT00484718

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
NSAID Index Knee Pain
Item
subject has been taking an nsaid at least 15 of the past 30 days for index knee pain
boolean
C0003211 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,4])
Osteoarthritis Femorotibial joint Medial Kellgren-Lawrence score | Index Joint X-ray
Item
grades 2 or 3 oa as defined by the kellgren and lawrence grading system of the medial tibiofemoral joint (joint space narrowing in the medial compartment > lateral compartment as assessed by x-ray) using the altman atlas of oa7. this must be documented with a report from an x-ray of the study joint taken either at screening or within 1 year prior to screening
boolean
C0029408 (UMLS CUI [1,1])
C1269072 (UMLS CUI [1,2])
C0205098 (UMLS CUI [1,3])
C3177117 (UMLS CUI [1,4])
C2986546 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
Knee Osteoarthritis ACR Criteria Fulfill | Knee pain | Age | Morning stiffness Duration | Joint crepitus | Bone tenderness | Bone enlargement | Joint warmth Synovial Membrane Palpable Absent
Item
subject meets american college of rheumatology (acr) clinical classification criteria for osteoarthritis of the knee, defined by the following: knee pain and at least 3 of the following: oage >50 omorning stiffness <30 minutes ocrepitus on active motion obony tenderness obony enlargement ono palpable warmth of synovium.
boolean
C0409959 (UMLS CUI [1,1])
C3273747 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0231749 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0457086 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
C0231592 (UMLS CUI [5])
C0238807 (UMLS CUI [6])
C2203582 (UMLS CUI [7])
C0240095 (UMLS CUI [8,1])
C0039099 (UMLS CUI [8,2])
C0522499 (UMLS CUI [8,3])
C0332197 (UMLS CUI [8,4])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction | Urticaria | Exanthema | Intolerance to celecoxib | Intolerance to Sulfonamides | Intolerance to Aspirin | Intolerance to Opioids | Intolerance to Oxycodone
Item
subject has a documented history of an allergic reaction (hives, rash, etc.) or a clinically significant intolerance to celecoxib, sulfonamides, aspirin, or opioids including oxycodone
boolean
C1527304 (UMLS CUI [1])
C0042109 (UMLS CUI [2])
C0015230 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0538927 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0038760 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0004057 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0242402 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0030049 (UMLS CUI [8,2])
Pain outside Index Knee | Hip pain Interferes with Ability to walk | Back Pain Interferes with Ability to walk | Osteoarthritis Pain | Bilateral primary osteoarthritis of knee allowed
Item
significant pain outside the index knee, including significant hip or back pain that can not be distinguished from oa pain or that interferes with ability to walk. (patients with bilateral knee oa will be allowed into the study. the index knee should be defined as the more painful knee
boolean
C0030193 (UMLS CUI [1,1])
C0205101 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0022742 (UMLS CUI [1,4])
C0019559 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0559964 (UMLS CUI [2,3])
C0004604 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0559964 (UMLS CUI [3,3])
C0029408 (UMLS CUI [4,1])
C0030193 (UMLS CUI [4,2])
C2893930 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
Patellofemoral osteoarthritis Index Knee Clinical examination
Item
predominantly patellofemoral knee osteoarthritis in the index knee as assessed by clinical examination
boolean
C1542808 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C1456356 (UMLS CUI [1,4])
Unable to discontinue Analgesics Formulation | Exception Acetaminophen | Other Coding | Aspirin Low Dose Cardiac prophylaxis allowed
Item
subject who are unable to discontinue all formulations of prior analgesics other than acetaminophen during the washout period of the study, or who are anticipated to be unable to discontinue rescue medication for 24 hours prior to the respective visits. (low dose aspirin may be taken for cardiac prophylaxis
boolean
C1548265 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
C0524527 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0000970 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
C2608320 (UMLS CUI [4,1])
C1739404 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Knee joint laxity Excessive | Indication Deficiency Ligament Functional
Item
excessive signal knee joint laxity indicative of functional ligamentous deficiency
boolean
C0574996 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0011155 (UMLS CUI [2,2])
C0023685 (UMLS CUI [2,3])
C0205245 (UMLS CUI [2,4])
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