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ID
31308
Description
A Study of GW842166 in Adults With Osteoarthritis Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00447486
Link
https://clinicaltrials.gov/show/NCT00447486
Keywords
Versions (2)
- 8/12/18 8/12/18 -
- 9/20/21 9/20/21 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
August 12, 2018
DOI
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License
Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT00447486
Eligibility Osteoarthritis, Knee NCT00447486
- StudyEvent: Eligibility
Similar models
Eligibility Osteoarthritis, Knee NCT00447486
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Age | Outpatients
Item
male or female outpatient, >= 40 years of age
boolean
C0001779 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C0029921 (UMLS CUI [2])
Knee Osteoarthritis idiopathic ACR Criteria Classification | Symptoms Duration
Item
meets acr clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
boolean
C0409959 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C3273747 (UMLS CUI [1,3])
C0008902 (UMLS CUI [1,4])
C1457887 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0332240 (UMLS CUI [1,2])
C3273747 (UMLS CUI [1,3])
C0008902 (UMLS CUI [1,4])
C1457887 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Other Coding | Functional Status
Item
meets ara functional status requirements
boolean
C3846158 (UMLS CUI [1])
C0598463 (UMLS CUI [2])
C0598463 (UMLS CUI [2])
WOMAC scale
Item
meets womac pain subscale score requirements
boolean
C3472647 (UMLS CUI [1])
Analgesic therapy Knee Osteoarthritis
Item
has taken analgesics for the treatment of their knee oa for at least 4 out of 7 days in each of the 4 weeks preceding screen
boolean
C0412784 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,2])
Abnormality Clinical Pre-specified | Abnormality biological Pre-specified | ECG abnormality Pre-specified
Item
any pre-specified clinical/biological/ecg abnormality
boolean
C1704258 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C2826245 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0205460 (UMLS CUI [2,2])
C2826245 (UMLS CUI [2,3])
C1832603 (UMLS CUI [3,1])
C2826245 (UMLS CUI [3,2])
C0205210 (UMLS CUI [1,2])
C2826245 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0205460 (UMLS CUI [2,2])
C2826245 (UMLS CUI [2,3])
C1832603 (UMLS CUI [3,1])
C2826245 (UMLS CUI [3,2])
Drug Allergy Pre-specified
Item
any pre-specified drug sensitivity
boolean
C0013182 (UMLS CUI [1,1])
C2826245 (UMLS CUI [1,2])
C2826245 (UMLS CUI [1,2])
Peptic Ulcer | Gastrointestinal Hemorrhage
Item
history of peptic ulceration or gi bleeding
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0017181 (UMLS CUI [2])
Pharmaceutical Preparations Protocol Specified
Item
use of protocol-specified medications
boolean
C0013227 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Cause Secondary Knee Osteoarthritis
Item
secondary cause of knee oa
boolean
C0015127 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,3])
C0175668 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,3])
Surgical procedure on lower extremity
Item
lower extremity surgery within 6 months of screening
boolean
C0187763 (UMLS CUI [1])
Analgesics | Exception Study Protocol allowed
Item
use of analgesics other than allowed per protocol
boolean
C0002771 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Adrenal Cortex Hormones | Hyaluronan
Item
use of corticosteroids or hyaluronan outside of allowed window prior to screening
boolean
C0001617 (UMLS CUI [1])
C0813622 (UMLS CUI [2])
C0813622 (UMLS CUI [2])