ID

22252

Descripción

A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00396955

Link

https://clinicaltrials.gov/show/NCT00396955

Palabras clave

Versiones (1)
  1. 26/5/17 26/5/17 -
Subido en

26 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00396955

Inglés

Eligibility Osteoarthritis NCT00396955

1 formularios  
Criteria
Descripción

Criteria

men or women 50 to 75 years of age. women must be of non-childbearing potential. sexually active men who are not surgically sterile must agree and commit to use of barrier contraception during the study and for at least 12 weeks after the last dose of pla.
Descripción

Age | Gender Childbearing Potential Absent | Gender Sexually active Barrier Contraception | Male sterilization | PLA-695

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0004764
UMLS CUI [4]
C0024559
UMLS CUI [5]
C3851282
diagnosed with idiopathic oa of the knee for at least 3 months duration in accordance with [1986] american college of rheumatology (acr) clinical and radiographic criteria: knee pain, the presence of osteophytes, and any one of the following: age >50 years, crepitus, or morning stiffness <30 minutes.
Descripción

Knee Osteoarthritis idiopathic Duration | Knee pain | Osteophyte Present | Age | crepitus | Morning stiffness Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0332240
UMLS CUI [1,3]
C0449238
UMLS CUI [2]
C0231749
UMLS CUI [3,1]
C1956089
UMLS CUI [3,2]
C0150312
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0277964
UMLS CUI [6,1]
C0457086
UMLS CUI [6,2]
C0449238
radiographic confirmation of oa at the target joint (weight-bearing anteroposterior and lateral views) within 1 year of screening.
Descripción

Degenerative polyarthritis Joint Target | Joint Weight Bearing anteroposterior view | Joint Weight Bearing View lateral

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1521840
UMLS CUI [2,1]
C0022417
UMLS CUI [2,2]
C0085086
UMLS CUI [2,3]
C3866438
UMLS CUI [3,1]
C0022417
UMLS CUI [3,2]
C0085086
UMLS CUI [3,3]
C1508423
must be currently treated for oa with a stable daily dose of 1 nsaid, including cox-2 inhibitors, not exceeding the maximum recommended dose in the product label, and taken as prescribed by the physician, starting at least 4 weeks before the screening visit.
Descripción

Degenerative polyarthritis Treated | Non-Steroidal Anti-Inflammatory Agents Quantity Dose Stable | Cyclooxygenase 2 Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3]
C1257954
exclusion criteria: these are some of the main exclusion criteria for the the study. additional exclusion are included in the protocol.
Descripción

Exclusion Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
history of or suspected current esophageal or gastrointestinal bleeding, ulcers, obstruction, or perforation, or pancreatitis.
Descripción

Esophageal bleeding | Gastrointestinal Hemorrhage | Ulcer | Obstruction | Perforation | Pancreatitis | Esophageal bleeding Suspected | Gastrointestinal Hemorrhage Suspected | Ulcer Suspected | Obstruction Suspected | Perforation Suspected | Pancreatitis Suspected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0239293
UMLS CUI [2]
C0017181
UMLS CUI [3]
C0041582
UMLS CUI [4]
C0028778
UMLS CUI [5]
C0549099
UMLS CUI [6]
C0030305
UMLS CUI [7,1]
C0239293
UMLS CUI [7,2]
C0750491
UMLS CUI [8,1]
C0017181
UMLS CUI [8,2]
C0750491
UMLS CUI [9,1]
C0041582
UMLS CUI [9,2]
C0750491
UMLS CUI [10,1]
C0028778
UMLS CUI [10,2]
C0750491
UMLS CUI [11,1]
C0549099
UMLS CUI [11,2]
C0750491
UMLS CUI [12,1]
C0030305
UMLS CUI [12,2]
C0750491
grade 4 severity on the kellgren-lawrence scale on the screening target knee radiograph.
Descripción

Knee Target radiography Kellgren-Lawrence score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022742
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0034571
UMLS CUI [1,4]
C3177117
any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory, neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal condition that the investigator considers detrimental to the subject's participating in the study or that may prevent the successful completion of the study.
Descripción

Condition Study Subject Participation Status Limited | Condition Preventing Clinical Trial Completion | Cardiovascular Diseases | Hematological Disease | Acute disease of hematopoietic system | Endocrine System Diseases | Respiration Disorders | nervous system disorder | Mental disorders | Metabolic Diseases | Immune System Diseases | Communicable Diseases | Liver diseases | Kidney Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0205197
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0018939
UMLS CUI [5]
C1263982
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0035204
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0004936
UMLS CUI [10]
C0025517
UMLS CUI [11]
C0021053
UMLS CUI [12]
C0009450
UMLS CUI [13]
C0023895
UMLS CUI [14]
C0022658
any clinically significant laboratory abnormality.
Descripción

Laboratory test result abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438215
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Similar models

Eligibility Osteoarthritis NCT00396955

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Age | Gender Childbearing Potential Absent | Gender Sexually active Barrier Contraception | Male sterilization | PLA-695
Item
men or women 50 to 75 years of age. women must be of non-childbearing potential. sexually active men who are not surgically sterile must agree and commit to use of barrier contraception during the study and for at least 12 weeks after the last dose of pla.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0004764 (UMLS CUI [3,3])
C0024559 (UMLS CUI [4])
C3851282 (UMLS CUI [5])
Knee Osteoarthritis idiopathic Duration | Knee pain | Osteophyte Present | Age | crepitus | Morning stiffness Duration
Item
diagnosed with idiopathic oa of the knee for at least 3 months duration in accordance with [1986] american college of rheumatology (acr) clinical and radiographic criteria: knee pain, the presence of osteophytes, and any one of the following: age >50 years, crepitus, or morning stiffness <30 minutes.
boolean
C0409959 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0231749 (UMLS CUI [2])
C1956089 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
C0277964 (UMLS CUI [5])
C0457086 (UMLS CUI [6,1])
C0449238 (UMLS CUI [6,2])
Degenerative polyarthritis Joint Target | Joint Weight Bearing anteroposterior view | Joint Weight Bearing View lateral
Item
radiographic confirmation of oa at the target joint (weight-bearing anteroposterior and lateral views) within 1 year of screening.
boolean
C0029408 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0022417 (UMLS CUI [2,1])
C0085086 (UMLS CUI [2,2])
C3866438 (UMLS CUI [2,3])
C0022417 (UMLS CUI [3,1])
C0085086 (UMLS CUI [3,2])
C1508423 (UMLS CUI [3,3])
Degenerative polyarthritis Treated | Non-Steroidal Anti-Inflammatory Agents Quantity Dose Stable | Cyclooxygenase 2 Inhibitors
Item
must be currently treated for oa with a stable daily dose of 1 nsaid, including cox-2 inhibitors, not exceeding the maximum recommended dose in the product label, and taken as prescribed by the physician, starting at least 4 weeks before the screening visit.
boolean
C0029408 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C1257954 (UMLS CUI [3])
Exclusion Criteria
Item
exclusion criteria: these are some of the main exclusion criteria for the the study. additional exclusion are included in the protocol.
boolean
C0680251 (UMLS CUI [1])
Esophageal bleeding | Gastrointestinal Hemorrhage | Ulcer | Obstruction | Perforation | Pancreatitis | Esophageal bleeding Suspected | Gastrointestinal Hemorrhage Suspected | Ulcer Suspected | Obstruction Suspected | Perforation Suspected | Pancreatitis Suspected
Item
history of or suspected current esophageal or gastrointestinal bleeding, ulcers, obstruction, or perforation, or pancreatitis.
boolean
C0239293 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0041582 (UMLS CUI [3])
C0028778 (UMLS CUI [4])
C0549099 (UMLS CUI [5])
C0030305 (UMLS CUI [6])
C0239293 (UMLS CUI [7,1])
C0750491 (UMLS CUI [7,2])
C0017181 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C0041582 (UMLS CUI [9,1])
C0750491 (UMLS CUI [9,2])
C0028778 (UMLS CUI [10,1])
C0750491 (UMLS CUI [10,2])
C0549099 (UMLS CUI [11,1])
C0750491 (UMLS CUI [11,2])
C0030305 (UMLS CUI [12,1])
C0750491 (UMLS CUI [12,2])
Knee Target radiography Kellgren-Lawrence score
Item
grade 4 severity on the kellgren-lawrence scale on the screening target knee radiograph.
boolean
C0022742 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C3177117 (UMLS CUI [1,4])
Condition Study Subject Participation Status Limited | Condition Preventing Clinical Trial Completion | Cardiovascular Diseases | Hematological Disease | Acute disease of hematopoietic system | Endocrine System Diseases | Respiration Disorders | nervous system disorder | Mental disorders | Metabolic Diseases | Immune System Diseases | Communicable Diseases | Liver diseases | Kidney Diseases
Item
any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory, neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal condition that the investigator considers detrimental to the subject's participating in the study or that may prevent the successful completion of the study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
C0007222 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C1263982 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0035204 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0004936 (UMLS CUI [9])
C0025517 (UMLS CUI [10])
C0021053 (UMLS CUI [11])
C0009450 (UMLS CUI [12])
C0023895 (UMLS CUI [13])
C0022658 (UMLS CUI [14])
Laboratory test result abnormal
Item
any clinically significant laboratory abnormality.
boolean
C0438215 (UMLS CUI [1])
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