ID

18748

Beschreibung

A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00404183

Link

https://clinicaltrials.gov/show/NCT00404183

Stichworte

Versionen (1)
  1. 18.11.16 18.11.16 -
Hochgeladen am

18. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Pain NCT00404183

Englisch

Eligibility Pain NCT00404183

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Pain NCT00404183
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females ages 21 to 75
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
has osteoarthritis of the hip or knee
Beschreibung

Osteoarthritis of hip | Osteoarthritis, Knee

Datentyp

boolean

Alias
UMLS CUI [1]
C0029410
UMLS CUI [2]
C0409959
requires therapeutic doses of medications for osteoarthritis
Beschreibung

Osteoarthritis | Pharmacotherapy Patient need for

Datentyp

boolean

Alias
UMLS CUI [1]
C0029408
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0686904
if female, must be of non-childbearing potential or practicing birth control
Beschreibung

Childbearing Potential Lacking | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
has sufficient pain to justify the use of round-the-clock opioids
Beschreibung

Opioid use Sustained Pain Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0240602
UMLS CUI [1,2]
C0443318
UMLS CUI [1,3]
C0030193
UMLS CUI [1,4]
C0439849
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
Beschreibung

Therapeutic procedure Osteoarthritis | Pharmaceutical Preparations Osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0029408
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0029408
has certain medical conditions which may interfere with pain assessments
Beschreibung

Medical condition Interferes with Pain Assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0030193
UMLS CUI [1,4]
C1516048
is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
Beschreibung

Hypersensitivity Hydrocodone | Hypersensitivity Opioids | Hypersensitivity Acetaminophen | Reaction Serious Hydrocodone | Reaction Serious Opioids | Reaction Serious Acetaminophen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0020264
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0242402
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0000970
UMLS CUI [4,1]
C0443286
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0020264
UMLS CUI [5,1]
C0443286
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0242402
UMLS CUI [6,1]
C0443286
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C0000970
has had certain infections, injuries or illnesses within the last month
Beschreibung

Communicable Diseases | Injuries | Illness

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C3263723
UMLS CUI [3]
C0221423
has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
Beschreibung

H/O: major abdominal surgery | Disease Causing Narrowing Intestinal | Constipation | Diarrhea | Nausea and vomiting

Datentyp

boolean

Alias
UMLS CUI [1]
C0455612
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C3854333
UMLS CUI [2,4]
C0021853
UMLS CUI [3]
C0009806
UMLS CUI [4]
C0011991
UMLS CUI [5]
C0027498
is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
Beschreibung

Chemotherapy | Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0006826
has a history of major psychiatric disorders or requires treatment with certain drugs for depression
Beschreibung

Mental disorders Major | Antidepressant therapy Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C1096649
UMLS CUI [2,2]
C0686904
cannot discontinue pain medications, even for a short time, prior to the study start
Beschreibung

Analgesics Discontinue Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
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Ähnliche Modelle

Eligibility Pain NCT00404183

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Pain NCT00404183
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males or females ages 21 to 75
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis of hip | Osteoarthritis, Knee
Item
has osteoarthritis of the hip or knee
boolean
C0029410 (UMLS CUI [1])
C0409959 (UMLS CUI [2])
Osteoarthritis | Pharmacotherapy Patient need for
Item
requires therapeutic doses of medications for osteoarthritis
boolean
C0029408 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Childbearing Potential Lacking | Childbearing Potential Contraceptive methods
Item
if female, must be of non-childbearing potential or practicing birth control
boolean
C3831118 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Opioid use Sustained Pain Related
Item
has sufficient pain to justify the use of round-the-clock opioids
boolean
C0240602 (UMLS CUI [1,1])
C0443318 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Osteoarthritis | Pharmaceutical Preparations Osteoarthritis
Item
has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
boolean
C0087111 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
Medical condition Interferes with Pain Assessment
Item
has certain medical conditions which may interfere with pain assessments
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
Hypersensitivity Hydrocodone | Hypersensitivity Opioids | Hypersensitivity Acetaminophen | Reaction Serious Hydrocodone | Reaction Serious Opioids | Reaction Serious Acetaminophen
Item
is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
boolean
C0020517 (UMLS CUI [1,1])
C0020264 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0242402 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
C0443286 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0020264 (UMLS CUI [4,3])
C0443286 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0242402 (UMLS CUI [5,3])
C0443286 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0000970 (UMLS CUI [6,3])
Communicable Diseases | Injuries | Illness
Item
has had certain infections, injuries or illnesses within the last month
boolean
C0009450 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
C0221423 (UMLS CUI [3])
H/O: major abdominal surgery | Disease Causing Narrowing Intestinal | Constipation | Diarrhea | Nausea and vomiting
Item
has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
boolean
C0455612 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C3854333 (UMLS CUI [2,3])
C0021853 (UMLS CUI [2,4])
C0009806 (UMLS CUI [3])
C0011991 (UMLS CUI [4])
C0027498 (UMLS CUI [5])
Chemotherapy | Malignant Neoplasms
Item
is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
boolean
C0392920 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Mental disorders Major | Antidepressant therapy Patient need for
Item
has a history of major psychiatric disorders or requires treatment with certain drugs for depression
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1096649 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Analgesics Discontinue Unable
Item
cannot discontinue pain medications, even for a short time, prior to the study start
boolean
C0002771 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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