ID

15734

Description

Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02355236

Link

https://clinicaltrials.gov/show/NCT02355236

Keywords

Versions (1)
  1. 6/10/16 6/10/16 -
Uploaded on

June 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT02355236

English

Eligibility Osteoarthritis NCT02355236

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
koreans given informed consent
Description

Informed Consent Korean

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1556095
patients who have ability of reading comprehension and completing questionnaires (eq-5d and vas)and have willingness to follow-up 12 weeks
Description

Able to read Questionnaires | Comprehension Questionnaires | Ability Completion Questionnaires | EuroQoL five dimension questionnaire | Visual Analog Scale | follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0034394
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0034394
UMLS CUI [3,1]
C0085732
UMLS CUI [3,2]
C0205197
UMLS CUI [3,3]
C0034394
UMLS CUI [4]
C2733251
UMLS CUI [5]
C3536884
UMLS CUI [6]
C1522577
patients with osteoarthritis symptoms confirmed by his/her medical history and with pain-vas of 40 and more
Description

Degenerative polyarthritis Symptoms | Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0042815
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who participate into other interventional study or had participated within 30 days before screening
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
alcohol or drug abuse within 6 months or alcohol consumption of 21 units and more in a week
Description

Substance Use Disorders | Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0001948
peptic ulcers accompanied with a complication such as bleeding, perforation, penetration or gastric outlet obstruction within 5 years, or a history of active peptic ulcer or peptic ulcer without a complication within 6 months at screening
Description

Peptic Ulcer Complication | Hemorrhage | Perforation | Peptic Ulcer Perforation | Gastric outlet obstruction | Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C0009566
UMLS CUI [2]
C0019080
UMLS CUI [3]
C0549099
UMLS CUI [4]
C0030925
UMLS CUI [5]
C0162651
UMLS CUI [6]
C0030920
patients who are known with helicobacter pylori infection but have not received any bacteriostatic treatment
Description

Helicobacter Infections untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0079487
UMLS CUI [1,2]
C0332155
known gastroesophageal reflux disease (gerd)
Description

Gastroesophageal reflux disease

Data type

boolean

Alias
UMLS CUI [1]
C0017168
any following joint diseases which may significant effect to the efficacy and safety assessments: septic arthritis, inflammatory joint arthritis such as rheumatoid arthritis, gout, recurrent pseudo-pain, paget's disease, joint fracture, joint ochronosis, acromegaly, hematochromatosis, wilson's disease, primary osteochondrosis, ehlers danlos syndrome, or other collagen genetic disorder
Description

Arthropathy | Arthritis, Infectious | Polyarthritis | Rheumatoid Arthritis | Gout | Paget's Disease | Joint Fracture | Joint Ochronosis | Acromegaly | Hemochromatosis | Hepatolenticular Degeneration | Osteochondrosis Primary | Ehlers-Danlos Syndrome | Hereditary Diseases Collagen

Data type

boolean

Alias
UMLS CUI [1]
C0022408
UMLS CUI [2]
C0003869
UMLS CUI [3]
C0162323
UMLS CUI [4]
C0003873
UMLS CUI [5]
C0018099
UMLS CUI [6]
C1368019
UMLS CUI [7,1]
C0022417
UMLS CUI [7,2]
C0016658
UMLS CUI [8,1]
C0022417
UMLS CUI [8,2]
C0028817
UMLS CUI [9]
C0001206
UMLS CUI [10]
C0018995
UMLS CUI [11]
C0019202
UMLS CUI [12,1]
C0029429
UMLS CUI [12,2]
C0205225
UMLS CUI [13]
C0013720
UMLS CUI [14,1]
C0019247
UMLS CUI [14,2]
C0009325
patients who are scheduled admissions to hospital for elective surgery during this study
Description

Hospital admission Elective Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0206058
history of gastrointestinal cancer
Description

Malignant neoplasm of gastrointestinal tract

Data type

boolean

Alias
UMLS CUI [1]
C0685938
gastrointestinal disorders related to drug malabsorption
Description

Gastrointestinal Diseases Due to Drug-induced malabsorption

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0267648
gastrointestinal bleeding, cerebral bleeding, other bleeding disorders, or severe hematological disorders
Description

Gastrointestinal Hemorrhage | Cerebral Hemorrhage | Blood Coagulation Disorders | Hematological Disease Severe

Data type

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2]
C2937358
UMLS CUI [3]
C0005779
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0205082
clinically significant diseases such as moderate or severe liver diseases (child pough class ii or more), severe heart failure or a history of coronary artery bypass graft (cabg), severe kidney diseases (crcl<30ml/min)
Description

Has Moderate or Severe Liver Disease | Heart failure Severe | Coronary Artery Bypass Surgery | Kidney Diseases Severe | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C3829821
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0010055
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0373595
know allergy experiences with any ingredient of study drugs or with other nasids or protocol pump inhibitors (ppis)
Description

Hypersensitivity Investigational New Drugs Ingredients | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0085993
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003211
patients who had had a joint surgery for osteoarthritis within 1 year
Description

Operation on joint Degenerative polyarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0185132
UMLS CUI [1,2]
C0029408
women of childbearing potential who do not agree with clinically appropriate contraception during this study
Description

Childbearing Potential | Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
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Similar models

Eligibility Osteoarthritis NCT02355236

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent Korean
Item
koreans given informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1556095 (UMLS CUI [1,2])
Able to read Questionnaires | Comprehension Questionnaires | Ability Completion Questionnaires | EuroQoL five dimension questionnaire | Visual Analog Scale | follow-up
Item
patients who have ability of reading comprehension and completing questionnaires (eq-5d and vas)and have willingness to follow-up 12 weeks
boolean
C0586740 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0085732 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0034394 (UMLS CUI [3,3])
C2733251 (UMLS CUI [4])
C3536884 (UMLS CUI [5])
C1522577 (UMLS CUI [6])
Degenerative polyarthritis Symptoms | Visual Analog Pain Scale
Item
patients with osteoarthritis symptoms confirmed by his/her medical history and with pain-vas of 40 and more
boolean
C0029408 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0042815 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
patients who participate into other interventional study or had participated within 30 days before screening
boolean
C2348568 (UMLS CUI [1])
Substance Use Disorders | Alcohol consumption
Item
alcohol or drug abuse within 6 months or alcohol consumption of 21 units and more in a week
boolean
C0038586 (UMLS CUI [1])
C0001948 (UMLS CUI [2])
Peptic Ulcer Complication | Hemorrhage | Perforation | Peptic Ulcer Perforation | Gastric outlet obstruction | Peptic Ulcer
Item
peptic ulcers accompanied with a complication such as bleeding, perforation, penetration or gastric outlet obstruction within 5 years, or a history of active peptic ulcer or peptic ulcer without a complication within 6 months at screening
boolean
C0030920 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2])
C0549099 (UMLS CUI [3])
C0030925 (UMLS CUI [4])
C0162651 (UMLS CUI [5])
C0030920 (UMLS CUI [6])
Helicobacter Infections untreated
Item
patients who are known with helicobacter pylori infection but have not received any bacteriostatic treatment
boolean
C0079487 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Gastroesophageal reflux disease
Item
known gastroesophageal reflux disease (gerd)
boolean
C0017168 (UMLS CUI [1])
Arthropathy | Arthritis, Infectious | Polyarthritis | Rheumatoid Arthritis | Gout | Paget's Disease | Joint Fracture | Joint Ochronosis | Acromegaly | Hemochromatosis | Hepatolenticular Degeneration | Osteochondrosis Primary | Ehlers-Danlos Syndrome | Hereditary Diseases Collagen
Item
any following joint diseases which may significant effect to the efficacy and safety assessments: septic arthritis, inflammatory joint arthritis such as rheumatoid arthritis, gout, recurrent pseudo-pain, paget's disease, joint fracture, joint ochronosis, acromegaly, hematochromatosis, wilson's disease, primary osteochondrosis, ehlers danlos syndrome, or other collagen genetic disorder
boolean
C0022408 (UMLS CUI [1])
C0003869 (UMLS CUI [2])
C0162323 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
C0018099 (UMLS CUI [5])
C1368019 (UMLS CUI [6])
C0022417 (UMLS CUI [7,1])
C0016658 (UMLS CUI [7,2])
C0022417 (UMLS CUI [8,1])
C0028817 (UMLS CUI [8,2])
C0001206 (UMLS CUI [9])
C0018995 (UMLS CUI [10])
C0019202 (UMLS CUI [11])
C0029429 (UMLS CUI [12,1])
C0205225 (UMLS CUI [12,2])
C0013720 (UMLS CUI [13])
C0019247 (UMLS CUI [14,1])
C0009325 (UMLS CUI [14,2])
Hospital admission Elective Surgical Procedures
Item
patients who are scheduled admissions to hospital for elective surgery during this study
boolean
C0184666 (UMLS CUI [1,1])
C0206058 (UMLS CUI [1,2])
Malignant neoplasm of gastrointestinal tract
Item
history of gastrointestinal cancer
boolean
C0685938 (UMLS CUI [1])
Gastrointestinal Diseases Due to Drug-induced malabsorption
Item
gastrointestinal disorders related to drug malabsorption
boolean
C0017178 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0267648 (UMLS CUI [1,3])
Gastrointestinal Hemorrhage | Cerebral Hemorrhage | Blood Coagulation Disorders | Hematological Disease Severe
Item
gastrointestinal bleeding, cerebral bleeding, other bleeding disorders, or severe hematological disorders
boolean
C0017181 (UMLS CUI [1])
C2937358 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
C0018939 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Has Moderate or Severe Liver Disease | Heart failure Severe | Coronary Artery Bypass Surgery | Kidney Diseases Severe | Creatinine clearance measurement
Item
clinically significant diseases such as moderate or severe liver diseases (child pough class ii or more), severe heart failure or a history of coronary artery bypass graft (cabg), severe kidney diseases (crcl<30ml/min)
boolean
C3829821 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3])
C0022658 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0373595 (UMLS CUI [5])
Hypersensitivity Investigational New Drugs Ingredients | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal
Item
know allergy experiences with any ingredient of study drugs or with other nasids or protocol pump inhibitors (ppis)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0085993 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
Operation on joint Degenerative polyarthritis
Item
patients who had had a joint surgery for osteoarthritis within 1 year
boolean
C0185132 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
Childbearing Potential | Contraceptive methods Unwilling
Item
women of childbearing potential who do not agree with clinically appropriate contraception during this study
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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