ID

22234

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00365586

Nyckelord

Versioner (1)
  1. 2017-05-24 2017-05-24 -
Uppladdad den

24 maj 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Osteoarthritis NCT00365586

Engelsk

Eligibility Osteoarthritis NCT00365586

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Unilateral primary osteoarthritis of knee | Bilateral primary osteoarthritis of knee

Datatyp

boolean

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

Pain criteria Fulfill

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

Urine pregnancy test positive | Pregnancy | Breast Feeding

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Arthropathy | Knee Replacement Arthroplasty Knee Involved

Datatyp

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
Beskrivning

Adrenal Cortex Hormones Injection | Hyaluronic Acid

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Renal Insufficiency | Hepatic impairment

Datatyp

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
Beskrivning

taking medication to help sleep Dose Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2054158
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443343
Tillbaka till toppen

Similar models

Eligibility Osteoarthritis NCT00365586

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial