ID

24811

Description

Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00504127

Link

https://clinicaltrials.gov/show/NCT00504127

Keywords

  1. 8/18/17 8/18/17 -
Uploaded on

August 18, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Osteoarthritis NCT00504127

Eligibility Osteoarthritis NCT00504127

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and woman (40 or older) with a diagnosis of primary oa of the knee.
Description

Age | Primary osteoarthritis of knee

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C2893931
must be a current chronic user of nsaids or acetaminophen
Description

NSAIDS chronic | Acetaminophen chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C0205191
must discontinue all analgesic therapy at screening
Description

Analgesics To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1272691
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled hypertension or diabetes
Description

Uncontrolled hypertension | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0011849
hepatic or renal impairment
Description

Hepatic impairment | Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1565489
current or expected use of anti-coagulant
Description

Anticoagulants | Anticoagulants Expected

Data type

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C1517001
clinical relevant abnormal ecg
Description

ECG abnormal Relevance Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
a history of alcohol or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
candidates for imminent joint replacement
Description

Joint replacement Anticipated

Data type

boolean

Alias
UMLS CUI [1,1]
C1442800
UMLS CUI [1,2]
C3840775
participation within 30 days prior to screening in another investigational study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Osteoarthritis NCT00504127

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Primary osteoarthritis of knee
Item
men and woman (40 or older) with a diagnosis of primary oa of the knee.
boolean
C0001779 (UMLS CUI [1])
C2893931 (UMLS CUI [2])
NSAIDS chronic | Acetaminophen chronic
Item
must be a current chronic user of nsaids or acetaminophen
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0000970 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Analgesics To be stopped
Item
must discontinue all analgesic therapy at screening
boolean
C0002771 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Uncontrolled hypertension | Diabetes Mellitus
Item
uncontrolled hypertension or diabetes
boolean
C1868885 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
Hepatic impairment | Renal Insufficiency
Item
hepatic or renal impairment
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Anticoagulants | Anticoagulants Expected
Item
current or expected use of anti-coagulant
boolean
C0003280 (UMLS CUI [1])
C0003280 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
ECG abnormal Relevance Clinical
Item
clinical relevant abnormal ecg
boolean
C0522055 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Substance Use Disorders
Item
a history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Joint replacement Anticipated
Item
candidates for imminent joint replacement
boolean
C1442800 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participation within 30 days prior to screening in another investigational study
boolean
C2348568 (UMLS CUI [1])

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