ID

31339

Descrição

Observational Study Investigating the Effectiveness of Fentanyl Matrix in Relieving Pain and Improving Function in Patients With Osteoarthritis of the Knee or Hip; ODM derived from: https://clinicaltrials.gov/show/NCT01119885

Link

https://clinicaltrials.gov/show/NCT01119885

Palavras-chave

Versões (1)
  1. 15/08/2018 15/08/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

15 de agosto de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Pain NCT01119885

Inglês

Eligibility Pain NCT01119885

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Pain NCT01119885
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who complain of chronic pain caused by osteoarthritis of the knee or hip persisting for 3 months or longer
Descrição

Chronic pain Duration | Etiology Knee Osteoarthritis | Etiology Osteoarthritis of hip

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0150055
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0409959
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0029410
patients who can fully observe the overall clinical study requirements including k-womac completion at the investigator's discretion
Descrição

Protocol Compliance | Other Coding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C3846158
patients who complain of severe pain (nrs score = 7) because pain was not treated enough with the previous analgesic
Descrição

Severe pain Numeric Pain Scale | Analgesic therapy Inadequate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0278140
UMLS CUI [1,2]
C1518471
UMLS CUI [2,1]
C0412784
UMLS CUI [2,2]
C0205412
patients who have never been administered strong opioid analgesics over the last one month
Descrição

Opioid Analgesics Strong Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0002772
UMLS CUI [1,2]
C0442821
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a history of the drug or alcohol abuse in the past or now
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
childbearing women who are pregnant or likely to be pregnant during the study period and male subjects who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)
Descrição

Childbearing Potential Pregnancy | Childbearing Potential Pregnancy Probably | Gender Fertility | Gender Sexual Abstinence Unwilling | Partner Contraceptive methods Absent | Contraceptive implant | Contraceptive injection | Contraceptives, Oral | Intrauterine Devices

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0750492
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0015895
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0036899
UMLS CUI [4,3]
C0558080
UMLS CUI [5,1]
C0682323
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C0332197
UMLS CUI [6]
C1657106
UMLS CUI [7]
C1656586
UMLS CUI [8]
C0009905
UMLS CUI [9]
C0021900
patients who are unable to use a transdermal system due to skin disease
Descrição

Use of Transdermal System Unable | Transdermal System Due to Dermatologic disorders

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0991556
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0991556
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0037274
patients with serious mental disorder
Descrição

Serious mental illness

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3841614
patients with history of hypersensitivity to opioid analgesics
Descrição

Opioid analgesic allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0570515
patients with history of co2 retention
Descrição

Hypercapnia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020440
patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
Descrição

Study Subject Participation Status Ineligible | Etiology Pharmaceutical Product Label Warning | Etiology Pharmaceutical Product Label Precaution | Etiology Pharmaceutical Product Label Medical contraindication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1705425
UMLS CUI [2,3]
C0687677
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1705425
UMLS CUI [3,3]
C1882442
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C1705425
UMLS CUI [4,3]
C1301624
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Similar models

Eligibility Pain NCT01119885

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Pain NCT01119885
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Chronic pain Duration | Etiology Knee Osteoarthritis | Etiology Osteoarthritis of hip
Item
patients who complain of chronic pain caused by osteoarthritis of the knee or hip persisting for 3 months or longer
boolean
C0150055 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0409959 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0029410 (UMLS CUI [3,2])
Protocol Compliance | Other Coding
Item
patients who can fully observe the overall clinical study requirements including k-womac completion at the investigator's discretion
boolean
C0525058 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Severe pain Numeric Pain Scale | Analgesic therapy Inadequate
Item
patients who complain of severe pain (nrs score = 7) because pain was not treated enough with the previous analgesic
boolean
C0278140 (UMLS CUI [1,1])
C1518471 (UMLS CUI [1,2])
C0412784 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Opioid Analgesics Strong Absent
Item
patients who have never been administered strong opioid analgesics over the last one month
boolean
C0002772 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders
Item
patients with a history of the drug or alcohol abuse in the past or now
boolean
C0038586 (UMLS CUI [1])
Childbearing Potential Pregnancy | Childbearing Potential Pregnancy Probably | Gender Fertility | Gender Sexual Abstinence Unwilling | Partner Contraceptive methods Absent | Contraceptive implant | Contraceptive injection | Contraceptives, Oral | Intrauterine Devices
Item
childbearing women who are pregnant or likely to be pregnant during the study period and male subjects who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0750492 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0015895 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C0682323 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C1657106 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C0009905 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
Use of Transdermal System Unable | Transdermal System Due to Dermatologic disorders
Item
patients who are unable to use a transdermal system due to skin disease
boolean
C1524063 (UMLS CUI [1,1])
C0991556 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0991556 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0037274 (UMLS CUI [2,3])
Serious mental illness
Item
patients with serious mental disorder
boolean
C3841614 (UMLS CUI [1])
Opioid analgesic allergy
Item
patients with history of hypersensitivity to opioid analgesics
boolean
C0570515 (UMLS CUI [1])
Hypercapnia
Item
patients with history of co2 retention
boolean
C0020440 (UMLS CUI [1])
Study Subject Participation Status Ineligible | Etiology Pharmaceutical Product Label Warning | Etiology Pharmaceutical Product Label Precaution | Etiology Pharmaceutical Product Label Medical contraindication
Item
patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C1705425 (UMLS CUI [2,2])
C0687677 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C1705425 (UMLS CUI [3,2])
C1882442 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C1705425 (UMLS CUI [4,2])
C1301624 (UMLS CUI [4,3])
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