ID

24847

Beschreibung

Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00589979

Link

https://clinicaltrials.gov/show/NCT00589979

Stichworte

Versionen (1)
  1. 19.08.17 19.08.17 -
Hochgeladen am

19. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Knee NCT00589979

Englisch

Eligibility Osteoarthritis of the Knee NCT00589979

1 Formulare  
Criteria
Beschreibung

Criteria

male or female patients ≥37 years with moderate-to-severe oa related pain in one knee
Beschreibung

Age | Knee pain Moderate Osteoarthritis Related | Knee pain Severe Osteoarthritis Related

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0231749
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C0029408
UMLS CUI [2,4]
C0439849
UMLS CUI [3,1]
C0231749
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0029408
UMLS CUI [3,4]
C0439849
body mass index (bmi) ≤40 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
symptomatic oa of the index knee diagnosed with a functional capacity of ii or iii according to acr criteria classification note: patients with symptomatic contralateral knee oa with persistent pain ≤2 cm on a 0-10 cm pi-nrs for ≥2 months will be allowed to participate.
Beschreibung

Knee Osteoarthritis Symptomatic Class Functional | Knee Osteoarthritis Contralateral Symptomatic | Pain persistent Duration Pain intensity rating scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0456387
UMLS CUI [1,4]
C0205245
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C0441988
UMLS CUI [2,3]
C0231220
UMLS CUI [3,1]
C0030193
UMLS CUI [3,2]
C0205322
UMLS CUI [3,3]
C0449238
UMLS CUI [3,4]
C1960637
unchanged dose of analgesic medication for oa for at least 4 weeks prior to screening and for the duration of the study
Beschreibung

Analgesics Dose unchanged Osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
UMLS CUI [1,4]
C0029408
able and willing to complete all paper and e-diary assessments required by protocol
Beschreibung

Protocol Compliance | Subject Diary Electronic Completion

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0013850
UMLS CUI [2,3]
C0205197
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint
Beschreibung

Joint Pain Interferes with Pain Joint Involved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1963066
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0030193
UMLS CUI [1,4]
C0022417
UMLS CUI [1,5]
C1314939
compromised integrity of the intact, superficial skin layer
Beschreibung

Skin layer Superficial Intact | Integrity At risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1282402
UMLS CUI [1,2]
C0205124
UMLS CUI [1,3]
C0205266
UMLS CUI [2,1]
C1947912
UMLS CUI [2,2]
C1444641
a grade 1 or 4 kellgren and lawrence score on radiographic examination
Beschreibung

Kellgren-Lawrence score Radiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3177117
UMLS CUI [1,2]
C0034571
recent injury to either knee causing pain and interference with daily activities (eg. walking)
Beschreibung

Knee Injury Causing Pain | Knee Injury Interferes with Daily activities | Knee Injury Interferes with Walking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022744
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0030193
UMLS CUI [2,1]
C0022744
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0871707
UMLS CUI [3,1]
C0022744
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0080331
recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and qol
Beschreibung

Operative procedure on knee Causing Pain | Operative procedure on knee Interferes with Assessment Pain | Operative procedure on knee Interferes with Assessment Function | Operative procedure on knee Interferes with Assessment Quality of life

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0187769
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0030193
UMLS CUI [2,1]
C0187769
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1516048
UMLS CUI [2,4]
C0030193
UMLS CUI [3,1]
C0187769
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1516048
UMLS CUI [3,4]
C0031843
UMLS CUI [4,1]
C0187769
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1516048
UMLS CUI [4,4]
C0034380
known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type, or any component of the product
Beschreibung

Lidocaine allergy | ANESTHETIC ALLERGY LOCAL AMIDE TYPE | Hypersensitivity Product Component

Datentyp

boolean

Alias
UMLS CUI [1]
C0570646
UMLS CUI [2]
C0741021
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1514468
UMLS CUI [3,3]
C1705248
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Ähnliche Modelle

Eligibility Osteoarthritis of the Knee NCT00589979

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age | Knee pain Moderate Osteoarthritis Related | Knee pain Severe Osteoarthritis Related
Item
male or female patients ≥37 years with moderate-to-severe oa related pain in one knee
boolean
C0001779 (UMLS CUI [1])
C0231749 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0029408 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
C0231749 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0029408 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
Body mass index
Item
body mass index (bmi) ≤40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Knee Osteoarthritis Symptomatic Class Functional | Knee Osteoarthritis Contralateral Symptomatic | Pain persistent Duration Pain intensity rating scale
Item
symptomatic oa of the index knee diagnosed with a functional capacity of ii or iii according to acr criteria classification note: patients with symptomatic contralateral knee oa with persistent pain ≤2 cm on a 0-10 cm pi-nrs for ≥2 months will be allowed to participate.
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0205245 (UMLS CUI [1,4])
C0409959 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C0030193 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C1960637 (UMLS CUI [3,4])
Analgesics Dose unchanged Osteoarthritis
Item
unchanged dose of analgesic medication for oa for at least 4 weeks prior to screening and for the duration of the study
boolean
C0002771 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0029408 (UMLS CUI [1,4])
Protocol Compliance | Subject Diary Electronic Completion
Item
able and willing to complete all paper and e-diary assessments required by protocol
boolean
C0525058 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0013850 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Joint Pain Interferes with Pain Joint Involved
Item
pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint
boolean
C1963066 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0022417 (UMLS CUI [1,4])
C1314939 (UMLS CUI [1,5])
Skin layer Superficial Intact | Integrity At risk
Item
compromised integrity of the intact, superficial skin layer
boolean
C1282402 (UMLS CUI [1,1])
C0205124 (UMLS CUI [1,2])
C0205266 (UMLS CUI [1,3])
C1947912 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
Kellgren-Lawrence score Radiography
Item
a grade 1 or 4 kellgren and lawrence score on radiographic examination
boolean
C3177117 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Knee Injury Causing Pain | Knee Injury Interferes with Daily activities | Knee Injury Interferes with Walking
Item
recent injury to either knee causing pain and interference with daily activities (eg. walking)
boolean
C0022744 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0022744 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0871707 (UMLS CUI [2,3])
C0022744 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0080331 (UMLS CUI [3,3])
Operative procedure on knee Causing Pain | Operative procedure on knee Interferes with Assessment Pain | Operative procedure on knee Interferes with Assessment Function | Operative procedure on knee Interferes with Assessment Quality of life
Item
recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and qol
boolean
C0187769 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0187769 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0030193 (UMLS CUI [2,4])
C0187769 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1516048 (UMLS CUI [3,3])
C0031843 (UMLS CUI [3,4])
C0187769 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1516048 (UMLS CUI [4,3])
C0034380 (UMLS CUI [4,4])
Lidocaine allergy | ANESTHETIC ALLERGY LOCAL AMIDE TYPE | Hypersensitivity Product Component
Item
known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type, or any component of the product
boolean
C0570646 (UMLS CUI [1])
C0741021 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C1514468 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
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