ID

36244

Description

Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT02205814

Link

https://clinicaltrials.gov/show/NCT02205814

Keywords

Versions (1)
  1. 4/24/19 4/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02205814

English

Eligibility Knee Osteoarthritis NCT02205814

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged 40 to 80 years with bmi < 30 kg/m²
Description

Age | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1305855
patient with kellgren-lawrence grade 2 to 3, symptomatic primary osteoarthritis at the index knee (acr criteria), for which an ia treatment is indicated
Description

Kellgren-Lawrence score | Knee Osteoarthritis Primary Symptomatic | Indication Therapeutic procedure Intraarticular

Data type

boolean

Alias
UMLS CUI [1]
C3177117
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C0231220
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0442108
pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
Description

Pain intensity Moderate | Pain intensity Severe | NSAIDs Dose chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C1320357
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205191
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
Description

Drug Allergy | Allergy to acetaminophen | Hypersensitivity Disinfectants

Data type

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0570513
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0012682
any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study
Description

Pharmacotherapy Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0009488
use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
Description

CORTICOSTEROIDS FOR SYSTEMIC USE U/day | Topical corticosteroids U/day | Prednisolone Equivalent U/day | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0304604
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0032950
UMLS CUI [3,2]
C0205163
UMLS CUI [3,3]
C0456683
UMLS CUI [4]
C0021081
current use of any pain or oa medication (e.g. nsaids, cox-2 inhibitors, analgesics, antidepressive agents), including topical treatments
Description

Analgesics | Pharmaceutical Preparations Osteoarthritis | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors | Antidepressive Agents | Treatment Topical

Data type

boolean

Alias
UMLS CUI [1]
C0002771
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0029408
UMLS CUI [3]
C0003211
UMLS CUI [4]
C1257954
UMLS CUI [5]
C0003289
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C1522168
viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
Description

Viscosupplementation Target Knee

Data type

boolean

Alias
UMLS CUI [1,1]
C2350507
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
Description

Liver disease | Renal Insufficiency Moderate | Renal Insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0205082
current use of any medications that are substrate of cyp3a4 and/or moderate or strong cyp3a4 inhibitors
Description

CYP3A4 Substrate | CYP3A4 Inhibitor Moderate | CYP3A4 Inhibitor Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C3714798
UMLS CUI [1,2]
C3891814
UMLS CUI [2,1]
C3830624
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C3830624
UMLS CUI [3,2]
C0442821
patients with any clinically relevant or unstable disease, or malignant neoplasms that, in the opinion of the investigator, may pose the patient at risk, or confound the efficacy and safety results of the study
Description

Disease At risk Patient | Malignant Neoplasms At risk Patient | Disease Interferes with Research results | Malignant Neoplasm Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0030705
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ecg parameters
Description

Laboratory test result abnormal | Abnormal vital signs | ECG abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0277804
UMLS CUI [3]
C0522055
pregnant and breastfeeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
Description

Signs Immunodeficiency | Signs Sepsis | Signs Knee infection | Signs Knee bursitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0021051
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0243026
UMLS CUI [3,1]
C0311392
UMLS CUI [3,2]
C1400580
UMLS CUI [4,1]
C0311392
UMLS CUI [4,2]
C0410092
patients with bleeding diathesis or on therapy with anticoagulants
Description

Bleeding tendency | Anticoagulant therapy

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0150457
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Similar models

Eligibility Knee Osteoarthritis NCT02205814

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Body mass index
Item
male or female patients aged 40 to 80 years with bmi < 30 kg/m²
boolean
C0001779 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Kellgren-Lawrence score | Knee Osteoarthritis Primary Symptomatic | Indication Therapeutic procedure Intraarticular
Item
patient with kellgren-lawrence grade 2 to 3, symptomatic primary osteoarthritis at the index knee (acr criteria), for which an ia treatment is indicated
boolean
C3177117 (UMLS CUI [1])
C0409959 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0442108 (UMLS CUI [3,3])
Pain intensity Moderate | Pain intensity Severe | NSAIDs Dose chronic
Item
pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
boolean
C1320357 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1320357 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Drug Allergy | Allergy to acetaminophen | Hypersensitivity Disinfectants
Item
history of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
boolean
C0013182 (UMLS CUI [1])
C0570513 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0012682 (UMLS CUI [3,2])
Pharmacotherapy Comorbidity
Item
any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study
boolean
C0013216 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
CORTICOSTEROIDS FOR SYSTEMIC USE U/day | Topical corticosteroids U/day | Prednisolone Equivalent U/day | Immunosuppressive Agents
Item
use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
boolean
C3653708 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0304604 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0032950 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C0021081 (UMLS CUI [4])
Analgesics | Pharmaceutical Preparations Osteoarthritis | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors | Antidepressive Agents | Treatment Topical
Item
current use of any pain or oa medication (e.g. nsaids, cox-2 inhibitors, analgesics, antidepressive agents), including topical treatments
boolean
C0002771 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3])
C1257954 (UMLS CUI [4])
C0003289 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C1522168 (UMLS CUI [6,2])
Viscosupplementation Target Knee
Item
viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
boolean
C2350507 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
Liver disease | Renal Insufficiency Moderate | Renal Insufficiency Severe
Item
evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
boolean
C0023895 (UMLS CUI [1])
C1565489 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C1565489 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
CYP3A4 Substrate | CYP3A4 Inhibitor Moderate | CYP3A4 Inhibitor Strong
Item
current use of any medications that are substrate of cyp3a4 and/or moderate or strong cyp3a4 inhibitors
boolean
C3714798 (UMLS CUI [1,1])
C3891814 (UMLS CUI [1,2])
C3830624 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3830624 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
Disease At risk Patient | Malignant Neoplasms At risk Patient | Disease Interferes with Research results | Malignant Neoplasm Interferes with Research results
Item
patients with any clinically relevant or unstable disease, or malignant neoplasms that, in the opinion of the investigator, may pose the patient at risk, or confound the efficacy and safety results of the study
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
Laboratory test result abnormal | Abnormal vital signs | ECG abnormal
Item
patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ecg parameters
boolean
C0438215 (UMLS CUI [1])
C0277804 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant and breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Signs Immunodeficiency | Signs Sepsis | Signs Knee infection | Signs Knee bursitis
Item
any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
boolean
C0311392 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0311392 (UMLS CUI [2,1])
C0243026 (UMLS CUI [2,2])
C0311392 (UMLS CUI [3,1])
C1400580 (UMLS CUI [3,2])
C0311392 (UMLS CUI [4,1])
C0410092 (UMLS CUI [4,2])
Bleeding tendency | Anticoagulant therapy
Item
patients with bleeding diathesis or on therapy with anticoagulants
boolean
C1458140 (UMLS CUI [1])
C0150457 (UMLS CUI [2])
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