ID

18688

Description

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

Keywords

Versions (1)
  1. 11/16/16 11/16/16 -
Uploaded on

November 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00609557

English

Eligibility Osteoarthritis NCT00609557

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 50-80
Description

Age

Data type

boolean

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

Osteoarthritis of hip | Osteoarthritis, Knee | Osteoarthritis, Spine

Data type

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.]
Description

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

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cannot read and write english
Description

Able to read English Language | Able to write English Language

Data type

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
Description

Impaired cognition Significant

Data type

boolean

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

Psychotic Disorders | Manic Disorder

Data type

boolean

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

Feeling suicidal

Data type

boolean

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

Substance Use Disorders | Substance Dependence

Data type

boolean

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

Opioids | Antidepressive Agents

Data type

boolean

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

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Osteoarthritis NCT00609557

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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