0 Evaluaciones

ID

18688

Descripción

A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00609557

Link

https://clinicaltrials.gov/show/NCT00609557

Palabras clave

  1. 16/11/16 16/11/16 -
Subido en

16 de noviembre de 2016

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Osteoarthritis NCT00609557

    Eligibility Osteoarthritis NCT00609557

    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age 50-80
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    physician diagnosis of oa in hip, knee or spine.
    Descripción

    Osteoarthritis of hip | Osteoarthritis, Knee | Osteoarthritis, Spine

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0029410
    UMLS CUI [2]
    C0409959
    UMLS CUI [3]
    C2350242
    significant activity limitation due to pain for at least one month on the western ontario and mcmasters university osteoarthritis index (womac) and average pain >5/10 on brief pain inventory despite adequate treatment with acetaminophen or nsaids. [this will identify an oa group with significant psychological distress and a desire for treatment.]
    Descripción

    Activity Limitation Significant Due to Pain | WOMAC osteoarthritis index | BPI - Pain on the Average | Acetaminophen | Anti-Inflammatory Agents, Non-Steroidal | Psychological distress Significant

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0026606
    UMLS CUI [1,2]
    C0449295
    UMLS CUI [1,3]
    C0750502
    UMLS CUI [1,4]
    C0678226
    UMLS CUI [1,5]
    C0030193
    UMLS CUI [2]
    C3472647
    UMLS CUI [3]
    C3639289
    UMLS CUI [4]
    C0000970
    UMLS CUI [5]
    C0003211
    UMLS CUI [6,1]
    C0815107
    UMLS CUI [6,2]
    C0750502
    depression status is not restricted, but will be monitored with prime-md interview and the scl-20. we anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation.
    Descripción

    Depressive disorder Status Restricted | PRIME-MD Interview Monitoring | Symptom checklist Depression scale | Depressive Symptoms

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0011581
    UMLS CUI [1,2]
    C0449438
    UMLS CUI [1,3]
    C0443288
    UMLS CUI [2,1]
    C2982364
    UMLS CUI [2,2]
    C0683518
    UMLS CUI [2,3]
    C1516647
    UMLS CUI [3,1]
    C0451524
    UMLS CUI [3,2]
    C0679604
    UMLS CUI [4]
    C0086132
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    cannot read and write english
    Descripción

    Able to read English Language | Able to write English Language

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0586740
    UMLS CUI [1,2]
    C0376245
    UMLS CUI [2,1]
    C0584993
    UMLS CUI [2,2]
    C0376245
    significant cognitive impairment
    Descripción

    Impaired cognition Significant

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0338656
    UMLS CUI [1,2]
    C0750502
    history of psychosis or mania
    Descripción

    Psychotic Disorders | Manic Disorder

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0033975
    UMLS CUI [2]
    C0024713
    current suicidal ideation
    Descripción

    Feeling suicidal

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0424000
    current substance abuse or dependence
    Descripción

    Substance Use Disorders | Substance Dependence

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0038580
    current use of opioids or any antidepressant medication
    Descripción

    Opioids | Antidepressive Agents

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0242402
    UMLS CUI [2]
    C0003289
    use of investigational drug within the past month
    Descripción

    Investigational New Drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0013230

    Similar models

    Eligibility Osteoarthritis NCT00609557

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age 50-80
    boolean
    C0001779 (UMLS CUI [1])
    Osteoarthritis of hip | Osteoarthritis, Knee | Osteoarthritis, Spine
    Item
    physician diagnosis of oa in hip, knee or spine.
    boolean
    C0029410 (UMLS CUI [1])
    C0409959 (UMLS CUI [2])
    C2350242 (UMLS CUI [3])
    Activity Limitation Significant Due to Pain | WOMAC osteoarthritis index | BPI - Pain on the Average | Acetaminophen | Anti-Inflammatory Agents, Non-Steroidal | Psychological distress Significant
    Item
    significant activity limitation due to pain for at least one month on the western ontario and mcmasters university osteoarthritis index (womac) and average pain >5/10 on brief pain inventory despite adequate treatment with acetaminophen or nsaids. [this will identify an oa group with significant psychological distress and a desire for treatment.]
    boolean
    C0026606 (UMLS CUI [1,1])
    C0449295 (UMLS CUI [1,2])
    C0750502 (UMLS CUI [1,3])
    C0678226 (UMLS CUI [1,4])
    C0030193 (UMLS CUI [1,5])
    C3472647 (UMLS CUI [2])
    C3639289 (UMLS CUI [3])
    C0000970 (UMLS CUI [4])
    C0003211 (UMLS CUI [5])
    C0815107 (UMLS CUI [6,1])
    C0750502 (UMLS CUI [6,2])
    Depressive disorder Status Restricted | PRIME-MD Interview Monitoring | Symptom checklist Depression scale | Depressive Symptoms
    Item
    depression status is not restricted, but will be monitored with prime-md interview and the scl-20. we anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation.
    boolean
    C0011581 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C0443288 (UMLS CUI [1,3])
    C2982364 (UMLS CUI [2,1])
    C0683518 (UMLS CUI [2,2])
    C1516647 (UMLS CUI [2,3])
    C0451524 (UMLS CUI [3,1])
    C0679604 (UMLS CUI [3,2])
    C0086132 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    Able to read English Language | Able to write English Language
    Item
    cannot read and write english
    boolean
    C0586740 (UMLS CUI [1,1])
    C0376245 (UMLS CUI [1,2])
    C0584993 (UMLS CUI [2,1])
    C0376245 (UMLS CUI [2,2])
    Impaired cognition Significant
    Item
    significant cognitive impairment
    boolean
    C0338656 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Psychotic Disorders | Manic Disorder
    Item
    history of psychosis or mania
    boolean
    C0033975 (UMLS CUI [1])
    C0024713 (UMLS CUI [2])
    Feeling suicidal
    Item
    current suicidal ideation
    boolean
    C0424000 (UMLS CUI [1])
    Substance Use Disorders | Substance Dependence
    Item
    current substance abuse or dependence
    boolean
    C0038586 (UMLS CUI [1])
    C0038580 (UMLS CUI [2])
    Opioids | Antidepressive Agents
    Item
    current use of opioids or any antidepressant medication
    boolean
    C0242402 (UMLS CUI [1])
    C0003289 (UMLS CUI [2])
    Investigational New Drugs
    Item
    use of investigational drug within the past month
    boolean
    C0013230 (UMLS CUI [1])

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