ID

22234

Beschrijving

Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00365586

Link

https://clinicaltrials.gov/show/NCT00365586

Trefwoorden

Versies (1)
  1. 24-05-17 24-05-17 -
Geüploaded op

24 mei 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00365586

Engels

Eligibility Osteoarthritis NCT00365586

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females 18 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of osteoarthritis of the knee (unilateral or bilateral)
Beschrijving

Unilateral primary osteoarthritis of knee | Bilateral primary osteoarthritis of knee

Datatype

boolean

Alias
UMLS CUI [1]
C2893932
UMLS CUI [2]
C2893930
meet pain entry criteria
Beschrijving

Pain criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
willing to discontinue use of all analgesic medications (including over-the-counter [otc] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes.
Beschrijving

Analgesics Discontinue Willing | Analgesics OTC - Over The Counter | Analgesics Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0002771
UMLS CUI [2,2]
C2709201
UMLS CUI [3,1]
C0002771
UMLS CUI [3,2]
C2348563
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive urine pregnancy test, pregnant or lactating.
Beschrijving

Urine pregnancy test positive | Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0430059
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or paget's disease
Beschrijving

Fibromyalgia | Arthritis | Gout | Pseudogout | Paget's Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0016053
UMLS CUI [2]
C0003864
UMLS CUI [3]
C0018099
UMLS CUI [4]
C0033802
UMLS CUI [5]
C1368019
have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee
Beschrijving

Arthropathy | Knee Replacement Arthroplasty Knee Involved

Datatype

boolean

Alias
UMLS CUI [1]
C0022408
UMLS CUI [2,1]
C0086511
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C1314939
have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit
Beschrijving

Adrenal Cortex Hormones Injection | Hyaluronic Acid

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1828121
UMLS CUI [2]
C0020196
have a history or physical examination finding that is incompatible with safe participation in the study or study product use
Beschrijving

Physical Examination | Finding Inconsistent Clinical Trial participation | Finding Inconsistent Investigational New Drug Use of

Datatype

boolean

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2,1]
C0243095
UMLS CUI [2,2]
C0442809
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0679823
UMLS CUI [3,1]
C0243095
UMLS CUI [3,2]
C0442809
UMLS CUI [3,3]
C0013230
UMLS CUI [3,4]
C1524063
are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
Beschrijving

Medical contraindication Pharmaceutical Preparations | Medical contraindication Substance | Investigational New Drugs | Drug Interactions

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0439861
UMLS CUI [3]
C0013230
UMLS CUI [4]
C0687133
have significant renal or hepatic impairment
Beschrijving

Renal Insufficiency | Hepatic impairment

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0948807
are taking a sleep medication at a dose that has not been stable for at least 3 months
Beschrijving

taking medication to help sleep Dose Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C2054158
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443343
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Similar models

Eligibility Osteoarthritis NCT00365586

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males or females 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Unilateral primary osteoarthritis of knee | Bilateral primary osteoarthritis of knee
Item
diagnosis of osteoarthritis of the knee (unilateral or bilateral)
boolean
C2893932 (UMLS CUI [1])
C2893930 (UMLS CUI [2])
Pain criteria Fulfill
Item
meet pain entry criteria
boolean
C0030193 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Analgesics Discontinue Willing | Analgesics OTC - Over The Counter | Analgesics Study Protocol
Item
willing to discontinue use of all analgesic medications (including over-the-counter [otc] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes.
boolean
C0002771 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0002771 (UMLS CUI [2,1])
C2709201 (UMLS CUI [2,2])
C0002771 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Urine pregnancy test positive | Pregnancy | Breast Feeding
Item
positive urine pregnancy test, pregnant or lactating.
boolean
C0430059 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Fibromyalgia | Arthritis | Gout | Pseudogout | Paget's Disease
Item
have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or paget's disease
boolean
C0016053 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
C0033802 (UMLS CUI [4])
C1368019 (UMLS CUI [5])
Arthropathy | Knee Replacement Arthroplasty Knee Involved
Item
have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee
boolean
C0022408 (UMLS CUI [1])
C0086511 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
Adrenal Cortex Hormones Injection | Hyaluronic Acid
Item
have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit
boolean
C0001617 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0020196 (UMLS CUI [2])
Physical Examination | Finding Inconsistent Clinical Trial participation | Finding Inconsistent Investigational New Drug Use of
Item
have a history or physical examination finding that is incompatible with safe participation in the study or study product use
boolean
C0031809 (UMLS CUI [1])
C0243095 (UMLS CUI [2,1])
C0442809 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0679823 (UMLS CUI [2,4])
C0243095 (UMLS CUI [3,1])
C0442809 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C1524063 (UMLS CUI [3,4])
Medical contraindication Pharmaceutical Preparations | Medical contraindication Substance | Investigational New Drugs | Drug Interactions
Item
are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
boolean
C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0439861 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3])
C0687133 (UMLS CUI [4])
Renal Insufficiency | Hepatic impairment
Item
have significant renal or hepatic impairment
boolean
C1565489 (UMLS CUI [1])
C0948807 (UMLS CUI [2])
taking medication to help sleep Dose Unstable
Item
are taking a sleep medication at a dose that has not been stable for at least 3 months
boolean
C2054158 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
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