ID

23476

Description

A Phase 3 Study to Evaluate the Long-Term Safety of ThermoProfen™ in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee.; ODM derived from: https://clinicaltrials.gov/show/NCT00532038

Link

https://clinicaltrials.gov/show/NCT00532038

Keywords

  1. 7/6/17 7/6/17 -
Uploaded on

July 6, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Osteoarthritis NCT00532038

Eligibility Osteoarthritis NCT00532038

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient completed a previous efficacy study of thermoprofen.
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0008976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a known allergy to nonsteroidal anti-inflammatory drugs (nsaids) (including aspirin).
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0746949
patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in thermoprofen (such as that found in adhesive bandages, e.g. band-aid®).
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
patient has asthma that has been induced or made worse by the use of aspirin or any other nsaid.
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0004057
UMLS CUI [1,3]
C0003211
patient has a relevant history of serious gastrointestinal disease.
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0017178
patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C0037274
patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0004936
patient is taking warfarin, heparin, or low molecular weight heparin.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C0019134
UMLS CUI [1,3]
C0019139
patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0009862

Similar models

Eligibility Osteoarthritis NCT00532038

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patient completed a previous efficacy study of thermoprofen.
boolean
C0008976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.2
Item
patient has a known allergy to nonsteroidal anti-inflammatory drugs (nsaids) (including aspirin).
boolean
C0020517 (UMLS CUI [1,1])
C0746949 (UMLS CUI [1,2])
ID.3
Item
patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in thermoprofen (such as that found in adhesive bandages, e.g. band-aid®).
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
ID.4
Item
patient has asthma that has been induced or made worse by the use of aspirin or any other nsaid.
boolean
C0004096 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
ID.5
Item
patient has a relevant history of serious gastrointestinal disease.
boolean
C0017178 (UMLS CUI [1])
ID.6
Item
patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
boolean
C0037274 (UMLS CUI [1])
ID.7
Item
patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
boolean
C0027765 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
ID.8
Item
patient is taking warfarin, heparin, or low molecular weight heparin.
boolean
C0043031 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0019139 (UMLS CUI [1,3])
ID.9
Item
patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0009862 (UMLS CUI [1,3])

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