ID

22705

Beskrivning

Efficacy and Safety Study of PG201 Tablet in Patients With Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01122485

Länk

https://clinicaltrials.gov/show/NCT01122485

Nyckelord

Versioner (1)
  1. 2017-06-10 2017-06-10 -
Uppladdad den

10 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Knee NCT01122485

Engelsk

Eligibility Osteoarthritis of the Knee NCT01122485

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients ≥40 and ≤ 75 years of age
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
for a woman, she should meet one of the following criteria to be eligible for the study: i) a woman of no childbearing potential ii) as for a woman of childbearing potential, she should have a negative pregnancy test result at screening and baseline/randomization
Beskrivning

childbearing potential, pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
patients should be able and willing to provide the written informed consent.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients should be able to read and understand the information provided for the study and be able to record the information requested by the study.
Beskrivning

able to read and understand the information provided for the study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C1273101
UMLS CUI [1,3]
C2697675
patients who meet the american college of rheumatology clinical plus radiographic classification criteria for idiopathic osteoarthritis of the knee, which are defined as follow: a patient who had knee pain and radiographically diagnosed osteophytes and met at least one of the followings. i) age> 50 years ii) morning stiffness for less than 30 minutes iii) crepitus during movement of the weight-bearing knee
Beskrivning

idiopathic osteoarthritis of the knee, knee pain and radiographically diagnosed osteophytes, age, morning stiffness, crepitus of weight-bearing knee

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0332240
UMLS CUI [2]
C0231749
UMLS CUI [3]
C2021136
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0457086
UMLS CUI [6,1]
C0231592
UMLS CUI [6,2]
C1318107
patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening.
Beskrivning

symptomatic primary osteoarthritis of the knee, duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231220
UMLS CUI [1,2]
C0409959
UMLS CUI [1,3]
C0449238
patients with severity of grade 2 or 3 according to kellgren & lawrence scale based on anteroposterior radiographic evidence of the tibiofemoral joints with osteoarthritis, and who are classified in functional class of i, ii or iii according to the american rheumatism association functional classification.
Beskrivning

kellgren & lawrence scale, functional class

Datatyp

boolean

Alias
UMLS CUI [1]
C3177117
UMLS CUI [2,1]
C0205245
UMLS CUI [2,2]
C0008902
patients who had a score of the western ontario and mcmaster universities osteoarthritis index (womac) pain subscale question 1 ≤80 mm at screening, a score of the western ontario and mcmaster universities osteoarthritis index (womac) pain subscale question 1 ≥50 mm at baseline. a decrease in the score of the western ontario and mcmaster universities osteoarthritis index (womac) pain subscale question 1 at least by 15mm from screening to baseline and a decrease in the patient self-assessed arthritis symptoms scores at least by one point from screening to baseline.
Beskrivning

womac

Datatyp

boolean

Alias
UMLS CUI [1]
C3472647
patients who received nonsteroidal antiinflammatory drugs (nsaids)/cyclooxygenase-2 inhibitor for the treatment of arthritis of the knee for at least 5 days a week during 4 weeks prior to screening
Beskrivning

nsaid, cox 2 inhibitor, osteoarthritis knee

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1257954
UMLS CUI [1,3]
C0409959
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a known hypersensitivity or intolerance to nonsteroidal antiinflammatory drugs (nsaids), aspirin or cyclooxygenase-2 inhibitor.
Beskrivning

hypersensitivity or intolerance to nonsteroidal antiinflammatory drugs (nsaids), aspirin or cyclooxygenase-2 inhibitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003211
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0004057
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1257954
patients with a clinical or biochemical abnormal finding (excluding any finding related to the investigating disease) at the screening visit, which in the investigator's opinion was considered to be clinically significant or might make safe participation in the study more difficult
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
patients with a history of gastroduodenal perforation and/or occlusion, gastric or duodenal surgery, progressive upper gastrointestinal ulcer within the last 6 months or a history of upper gastrointestinal bleeding (including hematemesis) within the last one year, lower gastrointestinal bleeding within the last one year (excluding hemorrhoid), inflammatory intestinal disease within the last 6 months, coronary artery disease, congestive heart failure or renal artery stenosis, stroke or transient ischemic attack.
Beskrivning

gastroduodenal perforation and/or occlusion, coronary artery disease, gastric or duodenal surgery, progressive upper gastrointestinal ulcer, upper gastrointestinal bleeding, lower gastrointestinal bleeding, inflammatory intestinal disease, coronary artery disease, congestive heart failure or renal artery stenosis, stroke or transient ischemic attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0519001
UMLS CUI [2,1]
C0450199
UMLS CUI [2,2]
C0028778
UMLS CUI [3]
C0192398
UMLS CUI [4]
C3837072
UMLS CUI [5,1]
C1282910
UMLS CUI [5,2]
C0237938
UMLS CUI [6]
C0041909
UMLS CUI [7]
C0024050
UMLS CUI [8]
C0021390
UMLS CUI [9]
C0010068
UMLS CUI [10]
C0018802
UMLS CUI [11]
C0035067
UMLS CUI [12]
C0038454
UMLS CUI [13]
C0007787
patients with uncontrollable hypertension
Beskrivning

uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
patients receiving aspirin therapy (low-dose aspirin in a daily dose of 325mg or less is permitted for prevention of cardiovascular disease).
Beskrivning

aspirin therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C4303556
patients receiving anticoagulant drug or antiplatelet drug (excluding low-dose aspirin) or who have a disease associated with hemostatic disorder.
Beskrivning

anticoagulant drug or antiplatelet drug, hemostatic disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0150457
UMLS CUI [2]
C1096021
UMLS CUI [3]
C0005779
patients with any of creatinine, bilirubin, alanine aminotransferase or aspartate aminotransferase > 1.5 times the upper lange of normal at screening. patients who have any two or more of bilirubin, alanine aminotransferase or aspartate aminotransferase level greater than the upper lange of normal will also be excluded.
Beskrivning

creatinine, bilirubin, ast, alt

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
patients with a history of drug or alcohol abuse.
Beskrivning

substance use disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Osteoarthritis of the Knee NCT01122485

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
patients ≥40 and ≤ 75 years of age
boolean
C0001779 (UMLS CUI [1])
childbearing potential, pregnancy test
Item
for a woman, she should meet one of the following criteria to be eligible for the study: i) a woman of no childbearing potential ii) as for a woman of childbearing potential, she should have a negative pregnancy test result at screening and baseline/randomization
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
informed consent
Item
patients should be able and willing to provide the written informed consent.
boolean
C0021430 (UMLS CUI [1])
able to read and understand the information provided for the study
Item
patients should be able to read and understand the information provided for the study and be able to record the information requested by the study.
boolean
C0586740 (UMLS CUI [1,1])
C1273101 (UMLS CUI [1,2])
C2697675 (UMLS CUI [1,3])
idiopathic osteoarthritis of the knee, knee pain and radiographically diagnosed osteophytes, age, morning stiffness, crepitus of weight-bearing knee
Item
patients who meet the american college of rheumatology clinical plus radiographic classification criteria for idiopathic osteoarthritis of the knee, which are defined as follow: a patient who had knee pain and radiographically diagnosed osteophytes and met at least one of the followings. i) age> 50 years ii) morning stiffness for less than 30 minutes iii) crepitus during movement of the weight-bearing knee
boolean
C0409959 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C0231749 (UMLS CUI [2])
C2021136 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0457086 (UMLS CUI [5])
C0231592 (UMLS CUI [6,1])
C1318107 (UMLS CUI [6,2])
symptomatic primary osteoarthritis of the knee, duration
Item
patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening.
boolean
C0231220 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
kellgren & lawrence scale, functional class
Item
patients with severity of grade 2 or 3 according to kellgren & lawrence scale based on anteroposterior radiographic evidence of the tibiofemoral joints with osteoarthritis, and who are classified in functional class of i, ii or iii according to the american rheumatism association functional classification.
boolean
C3177117 (UMLS CUI [1])
C0205245 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
womac
Item
patients who had a score of the western ontario and mcmaster universities osteoarthritis index (womac) pain subscale question 1 ≤80 mm at screening, a score of the western ontario and mcmaster universities osteoarthritis index (womac) pain subscale question 1 ≥50 mm at baseline. a decrease in the score of the western ontario and mcmaster universities osteoarthritis index (womac) pain subscale question 1 at least by 15mm from screening to baseline and a decrease in the patient self-assessed arthritis symptoms scores at least by one point from screening to baseline.
boolean
C3472647 (UMLS CUI [1])
nsaid, cox 2 inhibitor, osteoarthritis knee
Item
patients who received nonsteroidal antiinflammatory drugs (nsaids)/cyclooxygenase-2 inhibitor for the treatment of arthritis of the knee for at least 5 days a week during 4 weeks prior to screening
boolean
C0003211 (UMLS CUI [1,1])
C1257954 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
hypersensitivity or intolerance to nonsteroidal antiinflammatory drugs (nsaids), aspirin or cyclooxygenase-2 inhibitor
Item
patients with a known hypersensitivity or intolerance to nonsteroidal antiinflammatory drugs (nsaids), aspirin or cyclooxygenase-2 inhibitor.
boolean
C0020517 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1257954 (UMLS CUI [3,2])
comorbidity
Item
patients with a clinical or biochemical abnormal finding (excluding any finding related to the investigating disease) at the screening visit, which in the investigator's opinion was considered to be clinically significant or might make safe participation in the study more difficult
boolean
C0009488 (UMLS CUI [1])
gastroduodenal perforation and/or occlusion, coronary artery disease, gastric or duodenal surgery, progressive upper gastrointestinal ulcer, upper gastrointestinal bleeding, lower gastrointestinal bleeding, inflammatory intestinal disease, coronary artery disease, congestive heart failure or renal artery stenosis, stroke or transient ischemic attack
Item
patients with a history of gastroduodenal perforation and/or occlusion, gastric or duodenal surgery, progressive upper gastrointestinal ulcer within the last 6 months or a history of upper gastrointestinal bleeding (including hematemesis) within the last one year, lower gastrointestinal bleeding within the last one year (excluding hemorrhoid), inflammatory intestinal disease within the last 6 months, coronary artery disease, congestive heart failure or renal artery stenosis, stroke or transient ischemic attack.
boolean
C0519001 (UMLS CUI [1])
C0450199 (UMLS CUI [2,1])
C0028778 (UMLS CUI [2,2])
C0192398 (UMLS CUI [3])
C3837072 (UMLS CUI [4])
C1282910 (UMLS CUI [5,1])
C0237938 (UMLS CUI [5,2])
C0041909 (UMLS CUI [6])
C0024050 (UMLS CUI [7])
C0021390 (UMLS CUI [8])
C0010068 (UMLS CUI [9])
C0018802 (UMLS CUI [10])
C0035067 (UMLS CUI [11])
C0038454 (UMLS CUI [12])
C0007787 (UMLS CUI [13])
uncontrolled hypertension
Item
patients with uncontrollable hypertension
boolean
C1868885 (UMLS CUI [1])
aspirin therapy
Item
patients receiving aspirin therapy (low-dose aspirin in a daily dose of 325mg or less is permitted for prevention of cardiovascular disease).
boolean
C4303556 (UMLS CUI [1])
anticoagulant drug or antiplatelet drug, hemostatic disorder
Item
patients receiving anticoagulant drug or antiplatelet drug (excluding low-dose aspirin) or who have a disease associated with hemostatic disorder.
boolean
C0150457 (UMLS CUI [1])
C1096021 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
creatinine, bilirubin, ast, alt
Item
patients with any of creatinine, bilirubin, alanine aminotransferase or aspartate aminotransferase > 1.5 times the upper lange of normal at screening. patients who have any two or more of bilirubin, alanine aminotransferase or aspartate aminotransferase level greater than the upper lange of normal will also be excluded.
boolean
C0201976 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
substance use disorder
Item
patients with a history of drug or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
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