ID

36703

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02405793

Stichworte

Versionen (1)
  1. 03.06.19 03.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. Juni 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Osteoarthritis NCT02405793

Englisch

Eligibility Osteoarthritis NCT02405793

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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
Beschreibung

NSAIDs chronic Osteoarthritis Pain | Acetaminophen chronic Osteoarthritis Pain

Datentyp

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
Beschreibung

Analgesic therapy Discontinued

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Able to walk

Datentyp

boolean

Alias
UMLS CUI [1]
C2712089
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1377673
UMLS CUI [3]
C0013230
UMLS CUI [4]
C2346570
UMLS CUI [5]
C0949266
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Osteoarthritis NCT02405793

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video