ID

22231

Description

A Study of Pain Relief in Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00298974

Link

https://clinicaltrials.gov/show/NCT00298974

Keywords

Versions (1)
  1. 5/24/17 5/24/17 -
Uploaded on

May 24, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00298974

English

Eligibility Osteoarthritis NCT00298974

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females ages 21 to 80
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
if female, must be of non-child bearing potential or practicing birth control
Description

Gender Childbearing Potential Absent | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
has osteoarthritis of the hip or knee
Description

Osteoarthritis of hip | Osteoarthritis, Knee

Data type

boolean

Alias
UMLS CUI [1]
C0029410
UMLS CUI [2]
C0409959
requires therapeutic doses of medication for osteoarthritis pain
Description

Pharmacotherapy Degenerative polyarthritis Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0029408
UMLS CUI [1,3]
C0030193
has sufficient pain to justify the use of around-the-clock opioids
Description

Opioids Around the Clock Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0242402
UMLS CUI [1,2]
C1879738
UMLS CUI [1,3]
C0030193
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
is associated with any currently ongoing research study, or has previously participated in a vicodin cr study
Description

Study Subject Participation Status | Vicodin

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0483514
is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
Description

Hypersensitivity Hydrocodone | Allergic Reaction Hydrocodone | Hypersensitivity Opioids | Allergic Reaction Opioids | Hypersensitivity Acetaminophen | Allergic Reaction Acetaminophen

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0020264
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0020264
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0242402
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0242402
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0000970
UMLS CUI [6,1]
C1527304
UMLS CUI [6,2]
C0000970
cannot discontinue pain medications, even for the short time prior to the study start
Description

Analgesics Unable to discontinue

Data type

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1548265
has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
Description

Illness Significant | Traumatic injury | Laboratory test result abnormal | major surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C3263723
UMLS CUI [3]
C0438215
UMLS CUI [4]
C0679637
has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
Description

Gastric Bypass | Stenosis gastrointestinal Severe Pre-existing | Disease Narrowing Gastrointestinal tract

Data type

boolean

Alias
UMLS CUI [1]
C0017125
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0521362
UMLS CUI [2,3]
C0205082
UMLS CUI [2,4]
C2347662
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0333164
UMLS CUI [3,3]
C0017189
has a history of malnutrition or starvation
Description

Malnutrition | Starvation

Data type

boolean

Alias
UMLS CUI [1]
C0162429
UMLS CUI [2]
C0038187
has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
Description

Substance Use Disorders | Illicit drug use | Substance Dependence | Alcohol consumption Quantity per day

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0281875
UMLS CUI [3]
C0038580
UMLS CUI [4,1]
C0001948
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0439505
has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
Description

Single major depressive episode | Depressive disorder Pharmaceutical Preparations Patient need for | Mental disorder Major

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0686904
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205164
pregnant or breastfeeding females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
is incapacitated, bedridden or confined to a wheelchair
Description

Disability | Bedridden | WHEELCHAIR CONFINEMENT

Data type

boolean

Alias
UMLS CUI [1]
C0231170
UMLS CUI [2]
C0741453
UMLS CUI [3]
C0241735
has initiated any new therapy or medication for oa within 1 month of screening
Description

New therapy Degenerative polyarthritis | New medication commenced Degenerative polyarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C3242274
UMLS CUI [1,2]
C0029408
UMLS CUI [2,1]
C0420250
UMLS CUI [2,2]
C0029408
has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
Description

Operative Surgical Procedures Degenerative polyarthritis | Interventional procedure Degenerative polyarthritis | Pharmaceutical Preparations Degenerative polyarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0029408
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0029408
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0029408
has other conditions that may cause pain, such as rheumatoid arthritis or gout
Description

Condition Causing Pain | Rheumatoid Arthritis | Gout

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0030193
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0018099
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Similar models

Eligibility Osteoarthritis NCT00298974

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females ages 21 to 80
boolean
C0001779 (UMLS CUI [1])
Gender Childbearing Potential Absent | Gender Contraceptive methods
Item
if female, must be of non-child bearing potential or practicing birth control
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Osteoarthritis of hip | Osteoarthritis, Knee
Item
has osteoarthritis of the hip or knee
boolean
C0029410 (UMLS CUI [1])
C0409959 (UMLS CUI [2])
Pharmacotherapy Degenerative polyarthritis Pain
Item
requires therapeutic doses of medication for osteoarthritis pain
boolean
C0013216 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
Opioids Around the Clock Pain
Item
has sufficient pain to justify the use of around-the-clock opioids
boolean
C0242402 (UMLS CUI [1,1])
C1879738 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Vicodin
Item
is associated with any currently ongoing research study, or has previously participated in a vicodin cr study
boolean
C2348568 (UMLS CUI [1])
C0483514 (UMLS CUI [2])
Hypersensitivity Hydrocodone | Allergic Reaction Hydrocodone | Hypersensitivity Opioids | Allergic Reaction Opioids | Hypersensitivity Acetaminophen | Allergic Reaction Acetaminophen
Item
is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
boolean
C0020517 (UMLS CUI [1,1])
C0020264 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0020264 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0242402 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0242402 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0000970 (UMLS CUI [5,2])
C1527304 (UMLS CUI [6,1])
C0000970 (UMLS CUI [6,2])
Analgesics Unable to discontinue
Item
cannot discontinue pain medications, even for the short time prior to the study start
boolean
C0002771 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
Illness Significant | Traumatic injury | Laboratory test result abnormal | major surgery
Item
has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C3263723 (UMLS CUI [2])
C0438215 (UMLS CUI [3])
C0679637 (UMLS CUI [4])
Gastric Bypass | Stenosis gastrointestinal Severe Pre-existing | Disease Narrowing Gastrointestinal tract
Item
has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
boolean
C0017125 (UMLS CUI [1])
C1261287 (UMLS CUI [2,1])
C0521362 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C2347662 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0333164 (UMLS CUI [3,2])
C0017189 (UMLS CUI [3,3])
Malnutrition | Starvation
Item
has a history of malnutrition or starvation
boolean
C0162429 (UMLS CUI [1])
C0038187 (UMLS CUI [2])
Substance Use Disorders | Illicit drug use | Substance Dependence | Alcohol consumption Quantity per day
Item
has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
boolean
C0038586 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
C0001948 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0439505 (UMLS CUI [4,3])
Single major depressive episode | Depressive disorder Pharmaceutical Preparations Patient need for | Mental disorder Major
Item
has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
boolean
C0024517 (UMLS CUI [1])
C0011581 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disability | Bedridden | WHEELCHAIR CONFINEMENT
Item
is incapacitated, bedridden or confined to a wheelchair
boolean
C0231170 (UMLS CUI [1])
C0741453 (UMLS CUI [2])
C0241735 (UMLS CUI [3])
New therapy Degenerative polyarthritis | New medication commenced Degenerative polyarthritis
Item
has initiated any new therapy or medication for oa within 1 month of screening
boolean
C3242274 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0420250 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
Operative Surgical Procedures Degenerative polyarthritis | Interventional procedure Degenerative polyarthritis | Pharmaceutical Preparations Degenerative polyarthritis
Item
has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
boolean
C0543467 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0029408 (UMLS CUI [3,2])
Condition Causing Pain | Rheumatoid Arthritis | Gout
Item
has other conditions that may cause pain, such as rheumatoid arthritis or gout
boolean
C0348080 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0003873 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
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