ID

36703

Description

Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain; ODM derived from: https://clinicaltrials.gov/show/NCT02405793

Link

https://clinicaltrials.gov/show/NCT02405793

Keywords

Versions (1)
  1. 6/3/19 6/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT02405793

English

Eligibility Osteoarthritis NCT02405793

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary diagnosis of functional class i-iii osteoarthritis (oa) of the hip or knee
Description

Osteoarthritis of hip Kellgren-Lawrence score | Knee Osteoarthritis Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1,1]
C0029410
UMLS CUI [1,2]
C3177117
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C3177117
chronic user of nonsteroidal anti-inflammatory drugs (nsaids) and/or acetaminophen for oa pain
Description

NSAIDs chronic Osteoarthritis Pain | Acetaminophen chronic Osteoarthritis Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0029408
UMLS CUI [1,4]
C0030193
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0029408
UMLS CUI [2,4]
C0030193
discontinued all analgesic therapy at screening
Description

Analgesic therapy Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0412784
UMLS CUI [1,2]
C1444662
for women of childbearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Description

Childbearing Potential Pregnancy Absent | Childbearing Potential Breast Feeding Absent | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0006147
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
ability to ambulate
Description

Able to walk

Data type

boolean

Alias
UMLS CUI [1]
C2712089
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nsaids, including meloxicam
Description

Allergy to acetaminophen | Intolerance to Acetaminophen | Aspirin allergy | Intolerance to Aspirin | Non-steroidal anti-inflammatory drug allergy | Intolerance to NSAIDs | Hypersensitivity Meloxicam | Intolerance to Meloxicam

Data type

boolean

Alias
UMLS CUI [1]
C0570513
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0000970
UMLS CUI [3]
C0004058
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0004057
UMLS CUI [5]
C0570537
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0003211
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0083381
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0083381
requires regular (more than 2 doses per week) use of opioid or opioid combination products to control oa pain of the knee or hip
Description

Opioids Dose Quantity Weekly | Opioid Combination Product Dose Weekly | Pain control Knee Osteoarthritis | Pain control Osteoarthritis of hip

Data type

boolean

Alias
UMLS CUI [1,1]
C0242402
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332174
UMLS CUI [2,1]
C0242402
UMLS CUI [2,2]
C1880146
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0332174
UMLS CUI [3,1]
C0002766
UMLS CUI [3,2]
C0409959
UMLS CUI [4,1]
C0002766
UMLS CUI [4,2]
C0029410
clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
Description

Heart Disease Unstable | Respiration Disorder Unstable | Nervous system disorder Unstable | Immune System Disease Unstable | Hematological Disease Unstable | Kidney Disease Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0035204
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0021053
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0018939
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0443343
significant difficulties swallowing capsules/tablets or unable to tolerate oral medication
Description

Difficulty Swallowing Capsules | Difficulty Swallowing Tablets | Oral medication Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C4084787
UMLS CUI [1,2]
C0006935
UMLS CUI [2,1]
C4084787
UMLS CUI [2,2]
C0039225
UMLS CUI [3,1]
C0175795
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C1299582
previous participation in another clinical study of meloxicam capsules or received any investigational drug or device or investigational therapy within 30 days before screening
Description

Study Subject Participation Status | Meloxicam Capsule | Investigational New Drugs | Investigational Medical Device | Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1377673
UMLS CUI [3]
C0013230
UMLS CUI [4]
C2346570
UMLS CUI [5]
C0949266
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Similar models

Eligibility Osteoarthritis NCT02405793

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Osteoarthritis of hip Kellgren-Lawrence score | Knee Osteoarthritis Kellgren-Lawrence score
Item
primary diagnosis of functional class i-iii osteoarthritis (oa) of the hip or knee
boolean
C0029410 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0409959 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
NSAIDs chronic Osteoarthritis Pain | Acetaminophen chronic Osteoarthritis Pain
Item
chronic user of nonsteroidal anti-inflammatory drugs (nsaids) and/or acetaminophen for oa pain
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,4])
C0000970 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0029408 (UMLS CUI [2,3])
C0030193 (UMLS CUI [2,4])
Analgesic therapy Discontinued
Item
discontinued all analgesic therapy at screening
boolean
C0412784 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Childbearing Potential Pregnancy Absent | Childbearing Potential Breast Feeding Absent | Childbearing Potential Contraceptive methods
Item
for women of childbearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Able to walk
Item
ability to ambulate
boolean
C2712089 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allergy to acetaminophen | Intolerance to Acetaminophen | Aspirin allergy | Intolerance to Aspirin | Non-steroidal anti-inflammatory drug allergy | Intolerance to NSAIDs | Hypersensitivity Meloxicam | Intolerance to Meloxicam
Item
history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nsaids, including meloxicam
boolean
C0570513 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0000970 (UMLS CUI [2,2])
C0004058 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
C0570537 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0003211 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0083381 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0083381 (UMLS CUI [8,2])
Opioids Dose Quantity Weekly | Opioid Combination Product Dose Weekly | Pain control Knee Osteoarthritis | Pain control Osteoarthritis of hip
Item
requires regular (more than 2 doses per week) use of opioid or opioid combination products to control oa pain of the knee or hip
boolean
C0242402 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332174 (UMLS CUI [1,4])
C0242402 (UMLS CUI [2,1])
C1880146 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0332174 (UMLS CUI [2,4])
C0002766 (UMLS CUI [3,1])
C0409959 (UMLS CUI [3,2])
C0002766 (UMLS CUI [4,1])
C0029410 (UMLS CUI [4,2])
Heart Disease Unstable | Respiration Disorder Unstable | Nervous system disorder Unstable | Immune System Disease Unstable | Hematological Disease Unstable | Kidney Disease Unstable
Item
clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
boolean
C0018799 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0035204 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0021053 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0018939 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
Difficulty Swallowing Capsules | Difficulty Swallowing Tablets | Oral medication Receive Unable
Item
significant difficulties swallowing capsules/tablets or unable to tolerate oral medication
boolean
C4084787 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
C4084787 (UMLS CUI [2,1])
C0039225 (UMLS CUI [2,2])
C0175795 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Study Subject Participation Status | Meloxicam Capsule | Investigational New Drugs | Investigational Medical Device | Therapy, Investigational
Item
previous participation in another clinical study of meloxicam capsules or received any investigational drug or device or investigational therapy within 30 days before screening
boolean
C2348568 (UMLS CUI [1])
C1377673 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C2346570 (UMLS CUI [4])
C0949266 (UMLS CUI [5])
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