ID

40735

Beskrivning

Study on the Efficacy and Safety of Chondroitin Sulfate and Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01425853

Länk

https://clinicaltrials.gov/show/NCT01425853

Nyckelord

Versioner (1)
  1. 2020-05-06 2020-05-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 maj 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01425853

Engelsk

Eligibility Knee Osteoarthritis NCT01425853

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 40 years of age
Beskrivning

Age

Datatyp

boolean

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

Primary osteoarthritis of knee

Datatyp

boolean

Alias
UMLS CUI [1]
C2893931
oa of radiological stages ii or iii according to kellgren and lawrence
Beskrivning

Osteoarthritis Kellgren-Lawrence score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C3177117
patients with moderate-severe knee pain
Beskrivning

Knee pain Moderate | Knee pain Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0231749
UMLS CUI [2,2]
C0205082
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with active malignancy of any type or history of a malignancy within the last five years
Beskrivning

Malignant Neoplasm Type Any | History of malignant neoplasm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
UMLS CUI [2]
C0455471
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 spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
Beskrivning

Arthritis Interferes with Evaluation | Chondrocalcinosis | Paget's disease Target Knee | Rheumatoid Arthritis | Aseptic osteonecrosis | Gout | Arthritis, Infectious | Ochronosis | Acromegaly | Hemochromatosis | Wilson's disease | Osteochondromatosis | Spondyloarthropathy Seronegative | Mixed Connective Tissue Disease | Collagen-vascular disease | Psoriasis | Inflammatory Bowel Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0220825
UMLS CUI [2]
C0553730
UMLS CUI [3,1]
C0029401
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0022742
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
pain in other parts of the body greater than the knee pain that could interfere with the evaluation of the index joint
Beskrivning

Pain Interferes with Evaluation Joint

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0022417
patients with fibromyalgia
Beskrivning

Fibromyalgia

Datatyp

boolean

Alias
UMLS CUI [1]
C0016053
subjects with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious diseases of the heart
Beskrivning

Myocardial Infarction | Cerebrovascular accident | Chest Pain Relationship Heart Disease | Heart Diseases Serious

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0008031
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0018799
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0205404
subjects with high risk of cv events
Beskrivning

High risk of Cardiovascular event

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C1320716
subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, hiv positivity) or fungal infections
Beskrivning

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

Datatyp

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
subjects with a history of recurrent ugi ulceration or active inflammatory bowel disease (e.g., crohn's disease or ulcerative colitis), a significant coagulation defect
Beskrivning

Recurrent ulcer Upper Gastrointestinal Tract | Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis | Coagulation Defects

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0333294
UMLS CUI [1,2]
C3203348
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0010346
UMLS CUI [4]
C0009324
UMLS CUI [5]
C0005779
subjects who have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
Beskrivning

Ulcer of esophagus | Gastric ulcer | Prepyloric ulcer | Duodenal Ulcer

Datatyp

boolean

Alias
UMLS CUI [1]
C0151970
UMLS CUI [2]
C0038358
UMLS CUI [3]
C0267116
UMLS CUI [4]
C0013295
washout period for oa treatments before begginning the study.
Beskrivning

Washout Period Treatment Osteoarthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0029408
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Similar models

Eligibility Knee Osteoarthritis NCT01425853

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 40 years of age
boolean
C0001779 (UMLS CUI [1])
Primary osteoarthritis of knee
Item
primary oa of the knee according to the acr criteria
boolean
C2893931 (UMLS CUI [1])
Osteoarthritis Kellgren-Lawrence score
Item
oa of radiological stages ii or iii according to kellgren and lawrence
boolean
C0029408 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
Knee pain Moderate | Knee pain Severe
Item
patients with moderate-severe knee pain
boolean
C0231749 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0231749 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm Type Any | History of malignant neoplasm
Item
subjects with active malignancy of any type or history of a malignancy within the last five years
boolean
C0006826 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0455471 (UMLS CUI [2])
Arthritis Interferes with Evaluation | Chondrocalcinosis | Paget's disease Target Knee | Rheumatoid Arthritis | Aseptic osteonecrosis | Gout | Arthritis, Infectious | Ochronosis | Acromegaly | Hemochromatosis | Wilson's disease | Osteochondromatosis | Spondyloarthropathy Seronegative | Mixed Connective Tissue Disease | Collagen-vascular disease | Psoriasis | Inflammatory Bowel Disease
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 spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
boolean
C0003864 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0553730 (UMLS CUI [2])
C0029401 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0022742 (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])
Pain Interferes with Evaluation Joint
Item
pain in other parts of the body greater than the knee pain that could interfere with the evaluation of the index joint
boolean
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0022417 (UMLS CUI [1,4])
Fibromyalgia
Item
patients with fibromyalgia
boolean
C0016053 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Chest Pain Relationship Heart Disease | Heart Diseases Serious
Item
subjects with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious diseases of the heart
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0008031 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0018799 (UMLS CUI [3,3])
C0018799 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
High risk of Cardiovascular event
Item
subjects with high risk of cv events
boolean
C0332167 (UMLS CUI [1,1])
C1320716 (UMLS CUI [1,2])
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])
Recurrent ulcer Upper Gastrointestinal Tract | Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis | Coagulation Defects
Item
subjects with a history of recurrent ugi ulceration or active inflammatory bowel disease (e.g., crohn's disease or ulcerative colitis), a significant coagulation defect
boolean
C0333294 (UMLS CUI [1,1])
C3203348 (UMLS CUI [1,2])
C0021390 (UMLS CUI [2])
C0010346 (UMLS CUI [3])
C0009324 (UMLS CUI [4])
C0005779 (UMLS CUI [5])
Ulcer of esophagus | Gastric ulcer | Prepyloric ulcer | Duodenal Ulcer
Item
subjects who have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
boolean
C0151970 (UMLS CUI [1])
C0038358 (UMLS CUI [2])
C0267116 (UMLS CUI [3])
C0013295 (UMLS CUI [4])
Washout Period Treatment Osteoarthritis
Item
washout period for oa treatments before begginning the study.
boolean
C1710661 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
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