ID

31298

Descrição

HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00792727

Link

https://clinicaltrials.gov/show/NCT00792727

Palavras-chave

Versões (1)
  1. 10/08/2018 10/08/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

10 de agosto de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Osteoarthritis of the Knee NCT00792727

Inglês

Eligibility Osteoarthritis of the Knee NCT00792727

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
man or woman ≥45 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
clinical diagnosis of unilateral or bilateral oa of the knee
Descrição

Unilateral primary osteoarthritis of knee | Bilateral primary osteoarthritis of knee

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2893932
UMLS CUI [2]
C2893930
taking an nsaid or acetaminophen on a regular basis and has a history of knee pain amelioration with nsaid or acetaminophen use.
Descrição

NSAID Regular | Acetaminophen Regular | Medical History Knee pain improved by NSAIDs | Medical History Knee pain improved by Acetaminophen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C0205272
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C2110474
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C2110472
UMLS CUI [4,3]
C0000970
mild to moderate oa of the knee at the screening visit
Descrição

Knee Osteoarthritis Mild | Knee Osteoarthritis Moderate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C0205081
subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a nsaid or acetaminophen.
Descrição

Arthritis flare up Index Knee | NSAID Withdrawal | Acetaminophen Withdrawal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0857103
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022742
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C2349954
UMLS CUI [3,1]
C0000970
UMLS CUI [3,2]
C2349954
subject understands that treatment will be administered on an inpatient basis.
Descrição

Comprehension Inpatient treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0019993
subject is capable of understanding and complying with the protocol and has signed the informed consent document.
Descrição

Protocol Compliance | Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
Descrição

Childbearing Potential Urine pregnancy test positive | Childbearing Potential Breast Feeding | Childbearing Potential Female Sterilization Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430059
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0015787
UMLS CUI [3,3]
C0332197
subject has symptoms that are attributable to primary inflammatory diseases of the joint
Descrição

Symptoms Inflammatory joint disease Primary

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0683381
UMLS CUI [1,3]
C0205225
subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
Descrição

Unstable knee Physical Examination | Knee catches during movement | Knee Giving-way

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0427262
UMLS CUI [1,2]
C0031809
UMLS CUI [2]
C2109427
UMLS CUI [3,1]
C0022742
UMLS CUI [3,2]
C0231748
subject has arthropathies that occur in conjunction with systemic diseases
Descrição

Arthropathies Associated with Systemic disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022408
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0442893
subject has a chronic pain condition
Descrição

Chronic pain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0150055
subject is grossly obese
Descrição

Gross obesity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0857116
subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.
Descrição

Operative procedure on knee | Arthroscopy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0187769
UMLS CUI [2]
C0003904
subject has a history of osteotomies.
Descrição

Osteotomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029468
subject is not willing to discontinue the use of nsaids, acetaminophen or other prohibited treatments
Descrição

NSAIDs Discontinue Unwilling | Acetaminophen Discontinue Unwilling | Treatment Illicit Discontinue Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332266
UMLS CUI [3,3]
C1444662
UMLS CUI [3,4]
C0558080
subject used opioids for oa pain within 1 month
Descrição

Opioids Osteoarthritis Pain

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242402
UMLS CUI [1,2]
C0029408
UMLS CUI [1,3]
C0030193
Voltar ao início da página

Similar models

Eligibility Osteoarthritis of the Knee NCT00792727

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
man or woman ≥45 years of age.
boolean
C0001779 (UMLS CUI [1])
Unilateral primary osteoarthritis of knee | Bilateral primary osteoarthritis of knee
Item
clinical diagnosis of unilateral or bilateral oa of the knee
boolean
C2893932 (UMLS CUI [1])
C2893930 (UMLS CUI [2])
NSAID Regular | Acetaminophen Regular | Medical History Knee pain improved by NSAIDs | Medical History Knee pain improved by Acetaminophen
Item
taking an nsaid or acetaminophen on a regular basis and has a history of knee pain amelioration with nsaid or acetaminophen use.
boolean
C0003211 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0000970 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C2110474 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C2110472 (UMLS CUI [4,2])
C0000970 (UMLS CUI [4,3])
Knee Osteoarthritis Mild | Knee Osteoarthritis Moderate
Item
mild to moderate oa of the knee at the screening visit
boolean
C0409959 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0409959 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
Arthritis flare up Index Knee | NSAID Withdrawal | Acetaminophen Withdrawal
Item
subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a nsaid or acetaminophen.
boolean
C0857103 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C0000970 (UMLS CUI [3,1])
C2349954 (UMLS CUI [3,2])
Comprehension Inpatient treatment
Item
subject understands that treatment will be administered on an inpatient basis.
boolean
C0162340 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Protocol Compliance | Informed Consent
Item
subject is capable of understanding and complying with the protocol and has signed the informed consent document.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Urine pregnancy test positive | Childbearing Potential Breast Feeding | Childbearing Potential Female Sterilization Absent
Item
subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
boolean
C3831118 (UMLS CUI [1,1])
C0430059 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0015787 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Symptoms Inflammatory joint disease Primary
Item
subject has symptoms that are attributable to primary inflammatory diseases of the joint
boolean
C1457887 (UMLS CUI [1,1])
C0683381 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Unstable knee Physical Examination | Knee catches during movement | Knee Giving-way
Item
subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
boolean
C0427262 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C2109427 (UMLS CUI [2])
C0022742 (UMLS CUI [3,1])
C0231748 (UMLS CUI [3,2])
Arthropathies Associated with Systemic disease
Item
subject has arthropathies that occur in conjunction with systemic diseases
boolean
C0022408 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0442893 (UMLS CUI [1,3])
Chronic pain
Item
subject has a chronic pain condition
boolean
C0150055 (UMLS CUI [1])
Gross obesity
Item
subject is grossly obese
boolean
C0857116 (UMLS CUI [1])
Operative procedure on knee | Arthroscopy
Item
subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.
boolean
C0187769 (UMLS CUI [1])
C0003904 (UMLS CUI [2])
Osteotomy
Item
subject has a history of osteotomies.
boolean
C0029468 (UMLS CUI [1])
NSAIDs Discontinue Unwilling | Acetaminophen Discontinue Unwilling | Treatment Illicit Discontinue Unwilling
Item
subject is not willing to discontinue the use of nsaids, acetaminophen or other prohibited treatments
boolean
C0003211 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0000970 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0332266 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
Opioids Osteoarthritis Pain
Item
subject used opioids for oa pain within 1 month
boolean
C0242402 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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