ID

31297

Beschreibung

Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00722852

Link

https://clinicaltrials.gov/show/NCT00722852

Stichworte

Versionen (1)
  1. 10.08.18 10.08.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. 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.

Zurück zu Modell Kommentaren
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 of the Knee NCT00722852

Englisch

Eligibility Osteoarthritis of the Knee NCT00722852

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent signed and dated
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
age > 45 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
class i-iii oa of the knee and subject meets american college of rheumatology (acr) clinical classification criteria for osteoarthritis of the knee
Beschreibung

Knee Osteoarthritis Kellgren-Lawrence score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3177117
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
skin lesions or dermatological diseases in the treatment area
Beschreibung

Skin lesion Treatment Area | Dermatologic disorders Treatment Area

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205146
UMLS CUI [2,1]
C0037274
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205146
directly or indirectly involved in the conduct and administration of this study
Beschreibung

Involvement with Study Execution | Involvement with Study Administration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0681872
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C2603343
UMLS CUI [2,3]
C0001554
received any investigational medicinal product within 30 days prior to screening visit or participation in any previous clinical study with diractin®
Beschreibung

Investigational New Drugs | Study Subject Participation Status | Ketoprofen

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0022635
pregnancy or lactation
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
residents of psychiatric wards, prisons or other state institutions
Beschreibung

Resident Psychiatric ward | Resident Prisons

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347958
UMLS CUI [1,2]
C0599633
UMLS CUI [2,1]
C2347958
UMLS CUI [2,2]
C0033168
malignancy within the past 2 years
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
Beschreibung

Depressive disorder | Requirement Tricyclic Antidepressive Agents | Antidepressive Agents Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003290
UMLS CUI [3,1]
C0003289
UMLS CUI [3,2]
C0205360
epilepsy
Beschreibung

Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
schizophrenia
Beschreibung

Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
neuropathic pain and any other pain condition requiring chronic use of pain medication
Beschreibung

Neuropathic pain | Pain Requirement Analgesics chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C3714625
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0002771
UMLS CUI [2,4]
C0205191
known hypersensitivity or allergy (including photoallergy) to nsaid´s including ketoprofen and to ingredients of the imp
Beschreibung

Allergy to nonsteroidal anti-inflammatory agents | Photoallergy NSAIDs | Ketoprofen allergy | Photoallergy Ketoprofen | Hypersensitivity IMP Ingredient | Photoallergy IMP Ingredient

Datentyp

boolean

Alias
UMLS CUI [1]
C0746949
UMLS CUI [2,1]
C0206051
UMLS CUI [2,2]
C0003211
UMLS CUI [3]
C0570547
UMLS CUI [4,1]
C0206051
UMLS CUI [4,2]
C0022635
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0021533
UMLS CUI [5,3]
C1550600
UMLS CUI [6,1]
C0206051
UMLS CUI [6,2]
C0021533
UMLS CUI [6,3]
C1550600
preexisting asthma or bronchospasm after taking aspirin or other nsaids
Beschreibung

Asthma Pre-existing | Bronchial Spasm Post Intake Aspirin | Bronchial Spasm Post Intake NSAIDs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0006266
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1512806
UMLS CUI [2,4]
C0004057
UMLS CUI [3,1]
C0006266
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1512806
UMLS CUI [3,4]
C0003211
unable to discontinue analgesic therapy including opioids, nsaid´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study
Beschreibung

Unable to discontinue Analgesic therapy | Opioids | Anti-Inflammatory Agents, Non-Steroidal | Tramadol | Muscle relaxants | gabapentin | pregabalin | duloxetine | venlafaxine | Capsaicin | Pharmaceutical Preparations Treatment Pain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1548265
UMLS CUI [1,2]
C0412784
UMLS CUI [2]
C0242402
UMLS CUI [3]
C0003211
UMLS CUI [4]
C0040610
UMLS CUI [5]
C0358430
UMLS CUI [6]
C0060926
UMLS CUI [7]
C0657912
UMLS CUI [8]
C0245561
UMLS CUI [9]
C0078569
UMLS CUI [10]
C0006931
UMLS CUI [11,1]
C0013227
UMLS CUI [11,2]
C0087111
UMLS CUI [11,3]
C0030193
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Osteoarthritis of the Knee NCT00722852

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent signed and dated
boolean
C0021430 (UMLS CUI [1])
Age
Item
age > 45 years
boolean
C0001779 (UMLS CUI [1])
Knee Osteoarthritis Kellgren-Lawrence score
Item
class i-iii oa of the knee and subject meets american college of rheumatology (acr) clinical classification criteria for osteoarthritis of the knee
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Skin lesion Treatment Area | Dermatologic disorders Treatment Area
Item
skin lesions or dermatological diseases in the treatment area
boolean
C0037284 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0037274 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205146 (UMLS CUI [2,3])
Involvement with Study Execution | Involvement with Study Administration
Item
directly or indirectly involved in the conduct and administration of this study
boolean
C1314939 (UMLS CUI [1,1])
C0681872 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
C0001554 (UMLS CUI [2,3])
Investigational New Drugs | Study Subject Participation Status | Ketoprofen
Item
received any investigational medicinal product within 30 days prior to screening visit or participation in any previous clinical study with diractin®
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0022635 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Resident Psychiatric ward | Resident Prisons
Item
residents of psychiatric wards, prisons or other state institutions
boolean
C2347958 (UMLS CUI [1,1])
C0599633 (UMLS CUI [1,2])
C2347958 (UMLS CUI [2,1])
C0033168 (UMLS CUI [2,2])
Malignant Neoplasms
Item
malignancy within the past 2 years
boolean
C0006826 (UMLS CUI [1])
Depressive disorder | Requirement Tricyclic Antidepressive Agents | Antidepressive Agents Stable
Item
depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
boolean
C0011581 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0003290 (UMLS CUI [2,2])
C0003289 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Epilepsy
Item
epilepsy
boolean
C0014544 (UMLS CUI [1])
Schizophrenia
Item
schizophrenia
boolean
C0036341 (UMLS CUI [1])
Neuropathic pain | Pain Requirement Analgesics chronic
Item
neuropathic pain and any other pain condition requiring chronic use of pain medication
boolean
C3714625 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0002771 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
Allergy to nonsteroidal anti-inflammatory agents | Photoallergy NSAIDs | Ketoprofen allergy | Photoallergy Ketoprofen | Hypersensitivity IMP Ingredient | Photoallergy IMP Ingredient
Item
known hypersensitivity or allergy (including photoallergy) to nsaid´s including ketoprofen and to ingredients of the imp
boolean
C0746949 (UMLS CUI [1])
C0206051 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0570547 (UMLS CUI [3])
C0206051 (UMLS CUI [4,1])
C0022635 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0021533 (UMLS CUI [5,2])
C1550600 (UMLS CUI [5,3])
C0206051 (UMLS CUI [6,1])
C0021533 (UMLS CUI [6,2])
C1550600 (UMLS CUI [6,3])
Asthma Pre-existing | Bronchial Spasm Post Intake Aspirin | Bronchial Spasm Post Intake NSAIDs
Item
preexisting asthma or bronchospasm after taking aspirin or other nsaids
boolean
C0004096 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0006266 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1512806 (UMLS CUI [2,3])
C0004057 (UMLS CUI [2,4])
C0006266 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1512806 (UMLS CUI [3,3])
C0003211 (UMLS CUI [3,4])
Unable to discontinue Analgesic therapy | Opioids | Anti-Inflammatory Agents, Non-Steroidal | Tramadol | Muscle relaxants | gabapentin | pregabalin | duloxetine | venlafaxine | Capsaicin | Pharmaceutical Preparations Treatment Pain
Item
unable to discontinue analgesic therapy including opioids, nsaid´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study
boolean
C1548265 (UMLS CUI [1,1])
C0412784 (UMLS CUI [1,2])
C0242402 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
C0040610 (UMLS CUI [4])
C0358430 (UMLS CUI [5])
C0060926 (UMLS CUI [6])
C0657912 (UMLS CUI [7])
C0245561 (UMLS CUI [8])
C0078569 (UMLS CUI [9])
C0006931 (UMLS CUI [10])
C0013227 (UMLS CUI [11,1])
C0087111 (UMLS CUI [11,2])
C0030193 (UMLS CUI [11,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

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