ID

40768

Descripción

Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01893905

Link

https://clinicaltrials.gov/show/NCT01893905

Palabras clave

Versiones (1)
  1. 10/5/20 10/5/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

10 de mayo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01893905

Inglés

Eligibility Knee Osteoarthritis NCT01893905

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient >= 45 years .
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
primary oa of the knee according to acr criteria.
Descripción

Primary osteoarthritis of knee ACR Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2893931
UMLS CUI [1,2]
C3273747
oa radiological grade ii-iii according to kellgren and lawrence.
Descripción

Osteoarthritis Kellgren-Lawrence score Radiology

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C3177117
UMLS CUI [1,3]
C0043299
patients with moderate-severe pain.
Descripción

Moderate pain | Severe pain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0278139
UMLS CUI [2]
C0278140
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with clinical significant trauma or surgery in the target knee.
Descripción

Trauma Target Knee | Operative Surgical Procedure Target Knee

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3714660
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0022742
concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease or fibromyalgia.
Descripción

Arthritis Concurrent Interferes with Evaluation | Chondrocalcinosis | Paget's disease Limb Ipsilateral | Rheumatoid Arthritis | Osteonecrosis aseptic | Gout | Arthritis, Infectious | Ochronosis | Acromegaly | Hemochromatosis | Wilson's disease | Osteochondromatosis | Spondylarthropathy Seronegative | Mixed Connective Tissue Disease | Collagen-vascular disease | Psoriasis | Inflammatory Bowel Disease | Fibromyalgia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205420
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0220825
UMLS CUI [2]
C0221621
UMLS CUI [3,1]
C0029401
UMLS CUI [3,2]
C0015385
UMLS CUI [3,3]
C0441989
UMLS CUI [4]
C0003873
UMLS CUI [5]
C0391980
UMLS CUI [6]
C0018099
UMLS CUI [7]
C0003869
UMLS CUI [8]
C0028817
UMLS CUI [9]
C0001206
UMLS CUI [10]
C0018995
UMLS CUI [11]
C0019202
UMLS CUI [12]
C0206641
UMLS CUI [13,1]
C0949691
UMLS CUI [13,2]
C0521144
UMLS CUI [14]
C0026272
UMLS CUI [15]
C0262428
UMLS CUI [16]
C0033860
UMLS CUI [17]
C0021390
UMLS CUI [18]
C0016053
pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
Descripción

Pain Except Knee pain | Pain Interferes with Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0231749
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, hiv positivity) or fungal infections.
Descripción

Communicable Diseases Requirement Antibiotics | Chronic infectious disease Requirement Antibiotics | Virus Diseases Serious | Hepatitis | Herpes zoster | HIV Seropositivity | Mycoses Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
UMLS CUI [2,1]
C0151317
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C0019158
UMLS CUI [5]
C0019360
UMLS CUI [6]
C0019699
UMLS CUI [7,1]
C0026946
UMLS CUI [7,2]
C0205404
clinical diagnosis established of uncontrolled diabetes mellitus.
Descripción

Diabetic - poor control

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0421258
patients with asthma.
Descripción

Asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004096
history of hypersensitivity to the active drugs or any excipients of the formulations.
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipients

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
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Similar models

Eligibility Knee Osteoarthritis NCT01893905

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient >= 45 years .
boolean
C0001779 (UMLS CUI [1])
Primary osteoarthritis of knee ACR Criteria
Item
primary oa of the knee according to acr criteria.
boolean
C2893931 (UMLS CUI [1,1])
C3273747 (UMLS CUI [1,2])
Osteoarthritis Kellgren-Lawrence score Radiology
Item
oa radiological grade ii-iii according to kellgren and lawrence.
boolean
C0029408 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0043299 (UMLS CUI [1,3])
Moderate pain | Severe pain
Item
patients with moderate-severe pain.
boolean
C0278139 (UMLS CUI [1])
C0278140 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Trauma Target Knee | Operative Surgical Procedure Target Knee
Item
patients with clinical significant trauma or surgery in the target knee.
boolean
C3714660 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
Arthritis Concurrent Interferes with Evaluation | Chondrocalcinosis | Paget's disease Limb Ipsilateral | Rheumatoid Arthritis | Osteonecrosis aseptic | Gout | Arthritis, Infectious | Ochronosis | Acromegaly | Hemochromatosis | Wilson's disease | Osteochondromatosis | Spondylarthropathy Seronegative | Mixed Connective Tissue Disease | Collagen-vascular disease | Psoriasis | Inflammatory Bowel Disease | Fibromyalgia
Item
concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease or fibromyalgia.
boolean
C0003864 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C0221621 (UMLS CUI [2])
C0029401 (UMLS CUI [3,1])
C0015385 (UMLS CUI [3,2])
C0441989 (UMLS CUI [3,3])
C0003873 (UMLS CUI [4])
C0391980 (UMLS CUI [5])
C0018099 (UMLS CUI [6])
C0003869 (UMLS CUI [7])
C0028817 (UMLS CUI [8])
C0001206 (UMLS CUI [9])
C0018995 (UMLS CUI [10])
C0019202 (UMLS CUI [11])
C0206641 (UMLS CUI [12])
C0949691 (UMLS CUI [13,1])
C0521144 (UMLS CUI [13,2])
C0026272 (UMLS CUI [14])
C0262428 (UMLS CUI [15])
C0033860 (UMLS CUI [16])
C0021390 (UMLS CUI [17])
C0016053 (UMLS CUI [18])
Pain Except Knee pain | Pain Interferes with Evaluation
Item
pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
boolean
C0030193 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0231749 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
Communicable Diseases Requirement Antibiotics | Chronic infectious disease Requirement Antibiotics | Virus Diseases Serious | Hepatitis | Herpes zoster | HIV Seropositivity | Mycoses Serious
Item
subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, hiv positivity) or fungal infections.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0151317 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C0042769 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0019158 (UMLS CUI [4])
C0019360 (UMLS CUI [5])
C0019699 (UMLS CUI [6])
C0026946 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
Diabetic - poor control
Item
clinical diagnosis established of uncontrolled diabetes mellitus.
boolean
C0421258 (UMLS CUI [1])
Asthma
Item
patients with asthma.
boolean
C0004096 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipients
Item
history of hypersensitivity to the active drugs or any excipients of the formulations.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
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