ID

31308

Beschreibung

A Study of GW842166 in Adults With Osteoarthritis Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00447486

Link

https://clinicaltrials.gov/show/NCT00447486

Stichworte

  1. 12.08.18 12.08.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

12. August 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Osteoarthritis, Knee NCT00447486

Eligibility Osteoarthritis, Knee NCT00447486

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatient, >= 40 years of age
Beschreibung

Age | Outpatients

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0029921
meets acr clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
Beschreibung

Knee Osteoarthritis idiopathic ACR Criteria Classification | Symptoms Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0332240
UMLS CUI [1,3]
C3273747
UMLS CUI [1,4]
C0008902
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0449238
meets ara functional status requirements
Beschreibung

Other Coding | Functional Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0598463
meets womac pain subscale score requirements
Beschreibung

WOMAC scale

Datentyp

boolean

Alias
UMLS CUI [1]
C3472647
has taken analgesics for the treatment of their knee oa for at least 4 out of 7 days in each of the 4 weeks preceding screen
Beschreibung

Analgesic therapy Knee Osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0412784
UMLS CUI [1,2]
C0409959
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any pre-specified clinical/biological/ecg abnormality
Beschreibung

Abnormality Clinical Pre-specified | Abnormality biological Pre-specified | ECG abnormality Pre-specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C2826245
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0205460
UMLS CUI [2,3]
C2826245
UMLS CUI [3,1]
C1832603
UMLS CUI [3,2]
C2826245
any pre-specified drug sensitivity
Beschreibung

Drug Allergy Pre-specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C2826245
history of peptic ulceration or gi bleeding
Beschreibung

Peptic Ulcer | Gastrointestinal Hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0017181
use of protocol-specified medications
Beschreibung

Pharmaceutical Preparations Protocol Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0205369
secondary cause of knee oa
Beschreibung

Cause Secondary Knee Osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0409959
lower extremity surgery within 6 months of screening
Beschreibung

Surgical procedure on lower extremity

Datentyp

boolean

Alias
UMLS CUI [1]
C0187763
use of analgesics other than allowed per protocol
Beschreibung

Analgesics | Exception Study Protocol allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C0002771
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0683607
use of corticosteroids or hyaluronan outside of allowed window prior to screening
Beschreibung

Adrenal Cortex Hormones | Hyaluronan

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0813622

Ähnliche Modelle

Eligibility Osteoarthritis, Knee NCT00447486

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Outpatients
Item
male or female outpatient, >= 40 years of age
boolean
C0001779 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
Knee Osteoarthritis idiopathic ACR Criteria Classification | Symptoms Duration
Item
meets acr clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
boolean
C0409959 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C3273747 (UMLS CUI [1,3])
C0008902 (UMLS CUI [1,4])
C1457887 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Other Coding | Functional Status
Item
meets ara functional status requirements
boolean
C3846158 (UMLS CUI [1])
C0598463 (UMLS CUI [2])
WOMAC scale
Item
meets womac pain subscale score requirements
boolean
C3472647 (UMLS CUI [1])
Analgesic therapy Knee Osteoarthritis
Item
has taken analgesics for the treatment of their knee oa for at least 4 out of 7 days in each of the 4 weeks preceding screen
boolean
C0412784 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Abnormality Clinical Pre-specified | Abnormality biological Pre-specified | ECG abnormality Pre-specified
Item
any pre-specified clinical/biological/ecg abnormality
boolean
C1704258 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C2826245 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0205460 (UMLS CUI [2,2])
C2826245 (UMLS CUI [2,3])
C1832603 (UMLS CUI [3,1])
C2826245 (UMLS CUI [3,2])
Drug Allergy Pre-specified
Item
any pre-specified drug sensitivity
boolean
C0013182 (UMLS CUI [1,1])
C2826245 (UMLS CUI [1,2])
Peptic Ulcer | Gastrointestinal Hemorrhage
Item
history of peptic ulceration or gi bleeding
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
Pharmaceutical Preparations Protocol Specified
Item
use of protocol-specified medications
boolean
C0013227 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Cause Secondary Knee Osteoarthritis
Item
secondary cause of knee oa
boolean
C0015127 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,3])
Surgical procedure on lower extremity
Item
lower extremity surgery within 6 months of screening
boolean
C0187763 (UMLS CUI [1])
Analgesics | Exception Study Protocol allowed
Item
use of analgesics other than allowed per protocol
boolean
C0002771 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Adrenal Cortex Hormones | Hyaluronan
Item
use of corticosteroids or hyaluronan outside of allowed window prior to screening
boolean
C0001617 (UMLS CUI [1])
C0813622 (UMLS CUI [2])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video