ID

30138

Description

Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT01009671

Link

https://clinicaltrials.gov/show/NCT01009671

Keywords

Versions (1)
  1. 5/14/18 5/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01009671

English

Eligibility Knee Osteoarthritis NCT01009671

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female or male, aged 40 to 80 years, outpatient;
Description

Age | Outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0029921
presenting with internal femorotibial osteoarthritis:
Description

Degenerative polyarthritis Knee joint Internal

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0022745
UMLS CUI [1,3]
C0205102
symptomatic for more than 6 months;
Description

Disease Symptomatic Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0449238
meeting acr clinical and radiological criteria;
Description

Fulfill American College of Radiology Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1550543
UMLS CUI [1,2]
C1515941
UMLS CUI [1,3]
C0243161
overall mean vas score of knee pain in last 24 hours > 40 mm (with no nsaids for over 72 hours and no analgesics for over 24 hours);
Description

Knee pain mean Visual Analog Pain Scale | NSAIDs Absent | Analgesics Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C0042815
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0002771
UMLS CUI [3,2]
C0332197
pain present for at least one day out of 2 in the month preceding enrolment;
Description

Pain Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0449238
radiological stage ii to iii (kellgren and lawrence) (image less than 12 months old).
Description

Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1]
C3177117
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
associated predominant symptomatic femoropatellar osteoarthritis;
Description

Degenerative polyarthritis Patellofemoral joint Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0447801
UMLS CUI [1,3]
C0231220
chondromatosis or villonodular synovitis of the knee;
Description

Chondromatosis Knee | Villonodular synovitis of knee

Data type

boolean

Alias
UMLS CUI [1,1]
C0206636
UMLS CUI [1,2]
C0022742
UMLS CUI [2]
C0409777
paget's disease.
Description

Paget's Disease

Data type

boolean

Alias
UMLS CUI [1]
C1368019
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Similar models

Eligibility Knee Osteoarthritis NCT01009671

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Outpatients
Item
female or male, aged 40 to 80 years, outpatient;
boolean
C0001779 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
Degenerative polyarthritis Knee joint Internal
Item
presenting with internal femorotibial osteoarthritis:
boolean
C0029408 (UMLS CUI [1,1])
C0022745 (UMLS CUI [1,2])
C0205102 (UMLS CUI [1,3])
Disease Symptomatic Duration
Item
symptomatic for more than 6 months;
boolean
C0012634 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Fulfill American College of Radiology Criteria
Item
meeting acr clinical and radiological criteria;
boolean
C1550543 (UMLS CUI [1,1])
C1515941 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Knee pain mean Visual Analog Pain Scale | NSAIDs Absent | Analgesics Absent
Item
overall mean vas score of knee pain in last 24 hours > 40 mm (with no nsaids for over 72 hours and no analgesics for over 24 hours);
boolean
C0231749 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0042815 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0002771 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Pain Duration
Item
pain present for at least one day out of 2 in the month preceding enrolment;
boolean
C0030193 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Kellgren-Lawrence score
Item
radiological stage ii to iii (kellgren and lawrence) (image less than 12 months old).
boolean
C3177117 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Degenerative polyarthritis Patellofemoral joint Symptomatic
Item
associated predominant symptomatic femoropatellar osteoarthritis;
boolean
C0029408 (UMLS CUI [1,1])
C0447801 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Chondromatosis Knee | Villonodular synovitis of knee
Item
chondromatosis or villonodular synovitis of the knee;
boolean
C0206636 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0409777 (UMLS CUI [2])
Paget's Disease
Item
paget's disease.
boolean
C1368019 (UMLS CUI [1])
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