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

Lien

https://clinicaltrials.gov/show/NCT00609557

Mots-clés

Versions (1)
  1. 16/11/2016 16/11/2016 -
Téléchargé le

16 novembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Osteoarthritis NCT00609557

Anglais

Eligibility Osteoarthritis NCT00609557

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 50-80
Description

Age

Type de données

boolean

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

Osteoarthritis of hip | Osteoarthritis, Knee | Osteoarthritis, Spine

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Psychotic Disorders | Manic Disorder

Type de données

boolean

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

Feeling suicidal

Type de données

boolean

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

Substance Use Disorders | Substance Dependence

Type de données

boolean

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

Opioids | Antidepressive Agents

Type de données

boolean

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

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
Retour au début de la page

Similar models

Eligibility Osteoarthritis NCT00609557

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial