ID

31298

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00792727

Stichworte

Versionen (1)
  1. 10.08.18 10.08.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. August 2018

DOI

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Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Knee NCT00792727

Englisch

Eligibility Osteoarthritis of the Knee NCT00792727

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Unilateral primary osteoarthritis of knee | Bilateral primary osteoarthritis of knee

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Knee Osteoarthritis Mild | Knee Osteoarthritis Moderate

Datentyp

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.
Beschreibung

Arthritis flare up Index Knee | NSAID Withdrawal | Acetaminophen Withdrawal

Datentyp

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.
Beschreibung

Comprehension Inpatient treatment

Datentyp

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.
Beschreibung

Protocol Compliance | Informed Consent

Datentyp

boolean

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

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
Beschreibung

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

Datentyp

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
Beschreibung

Symptoms Inflammatory joint disease Primary

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Arthropathies Associated with Systemic disease

Datentyp

boolean

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

Chronic pain

Datentyp

boolean

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

Gross obesity

Datentyp

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.
Beschreibung

Operative procedure on knee | Arthroscopy

Datentyp

boolean

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

Osteotomy

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Opioids Osteoarthritis Pain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242402
UMLS CUI [1,2]
C0029408
UMLS CUI [1,3]
C0030193
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Ähnliche Modelle

Eligibility Osteoarthritis of the Knee NCT00792727

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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