ID

31297

Description

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

Lien

https://clinicaltrials.gov/show/NCT00722852

Mots-clés

Versions (1)
  1. 10/08/2018 10/08/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

10 août 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Knee NCT00722852

Anglais

Eligibility Osteoarthritis of the Knee NCT00722852

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent signed and dated
Description

Informed Consent

Type de données

boolean

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

Age

Type de données

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
Description

Knee Osteoarthritis Kellgren-Lawrence score

Type de données

boolean

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

Exclusion Criteria

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

Skin lesion Treatment Area | Dermatologic disorders Treatment Area

Type de données

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
Description

Involvement with Study Execution | Involvement with Study Administration

Type de données

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®
Description

Investigational New Drugs | Study Subject Participation Status | Ketoprofen

Type de données

boolean

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

Pregnancy | Breast Feeding

Type de données

boolean

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

Resident Psychiatric ward | Resident Prisons

Type de données

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
Description

Malignant Neoplasms

Type de données

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
Description

Depressive disorder | Requirement Tricyclic Antidepressive Agents | Antidepressive Agents Stable

Type de données

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
Description

Epilepsy

Type de données

boolean

Alias
UMLS CUI [1]
C0014544
schizophrenia
Description

Schizophrenia

Type de données

boolean

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

Neuropathic pain | Pain Requirement Analgesics chronic

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

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
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Similar models

Eligibility Osteoarthritis of the Knee NCT00722852

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
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