ID

19360

Beschreibung

Examining Rapid Acting Intra-Muscular Olanzapine in Japanese Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00485810

Link

https://clinicaltrials.gov/show/NCT00485810

Stichworte

Versionen (1)
  1. 21.12.16 21.12.16 -
Hochgeladen am

21. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00485810

Englisch

Eligibility Schizophrenia NCT00485810

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients at least 20 years of age and less than 65 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients must be inpatients during the study
Beschreibung

inpatient

Datentyp

boolean

Alias
UMLS CUI [1]
C0021562
patients must have a diagnosis of schizophrenia as per the dsm-iv, as determined by the investigator
Beschreibung

Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
patients must be considered by the investigator to be clinically agitated and to be clinically appropriate candidates for the treatment with intramuscular (im) medication
Beschreibung

Agitated Clinical | Indication Pharmaceutical Preparations Intramuscular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085631
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1556154
patients must have a minimum total score of greater than or equal to 14 on the 5 items of the panss-ec and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system, prior to the first im injection of study drug
Beschreibung

Positive and negative syndrome scale

Datentyp

boolean

Alias
UMLS CUI [1]
C0451383
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. this includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases
Beschreibung

Illness Unstable Serious | Cessation of life Anticipated | Disease Intensive care unit Anticipated | Liver diseases | Icterus Degree Any | Kidney Diseases | Gastroenterology Disease | Respiration Disorders | Cardiovascular Diseases | Myocardial Ischemia | Endocrine System Diseases | nervous system disorder | Immune System Diseases | Hematological Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0011065
UMLS CUI [2,2]
C3840775
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0021708
UMLS CUI [3,3]
C3840775
UMLS CUI [4]
C0023895
UMLS CUI [5,1]
C0022346
UMLS CUI [5,2]
C0441889
UMLS CUI [5,3]
C1552551
UMLS CUI [6]
C0022658
UMLS CUI [7,1]
C0017163
UMLS CUI [7,2]
C0012634
UMLS CUI [8]
C0035204
UMLS CUI [9]
C0007222
UMLS CUI [10]
C0151744
UMLS CUI [11]
C0014130
UMLS CUI [12]
C0027765
UMLS CUI [13]
C0021053
UMLS CUI [14]
C0018939
known history of seizures; however, a patient whose etiology is identifiable and has been resolved may be enrolled
Beschreibung

Seizures | Patient Etiology | Patient Resolved

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1314792
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C3714811
known history of diabetes mellitus, complications of diabetes mellitus, or potential diabetes mellitus as defined by patients with single blood glucose measurement based on site tests; patients with values greater than or equal to 140 mg/dl (non-fasting) or greater than or equal to 110 mg/dl (fasting) must be excluded from the study
Beschreibung

Diabetes Mellitus | Complications of Diabetes Mellitus | Diabetes Mellitus potential | Blood glucose measurement Single | Fasting blood glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0342257
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C3245505
UMLS CUI [4,1]
C0392201
UMLS CUI [4,2]
C0205171
UMLS CUI [5]
C0428568
history of allergic reaction or intolerance to olanzapine
Beschreibung

Allergic Reaction olanzapine | intolerance to olanzapine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0171023
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0171023
have received treatment with psychostimulants or reserpine within 1 week prior to study drug administration
Beschreibung

Psychostimulant | Reserpine

Datentyp

boolean

Alias
UMLS CUI [1]
C0304403
UMLS CUI [2]
C0035179
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Ähnliche Modelle

Eligibility Schizophrenia NCT00485810

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients at least 20 years of age and less than 65 years old
boolean
C0001779 (UMLS CUI [1])
inpatient
Item
patients must be inpatients during the study
boolean
C0021562 (UMLS CUI [1])
Schizophrenia
Item
patients must have a diagnosis of schizophrenia as per the dsm-iv, as determined by the investigator
boolean
C0036341 (UMLS CUI [1])
Agitated Clinical | Indication Pharmaceutical Preparations Intramuscular
Item
patients must be considered by the investigator to be clinically agitated and to be clinically appropriate candidates for the treatment with intramuscular (im) medication
boolean
C0085631 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1556154 (UMLS CUI [2,3])
Positive and negative syndrome scale
Item
patients must have a minimum total score of greater than or equal to 14 on the 5 items of the panss-ec and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system, prior to the first im injection of study drug
boolean
C0451383 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Illness Unstable Serious | Cessation of life Anticipated | Disease Intensive care unit Anticipated | Liver diseases | Icterus Degree Any | Kidney Diseases | Gastroenterology Disease | Respiration Disorders | Cardiovascular Diseases | Myocardial Ischemia | Endocrine System Diseases | nervous system disorder | Immune System Diseases | Hematological Disease
Item
serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. this includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0011065 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0021708 (UMLS CUI [3,2])
C3840775 (UMLS CUI [3,3])
C0023895 (UMLS CUI [4])
C0022346 (UMLS CUI [5,1])
C0441889 (UMLS CUI [5,2])
C1552551 (UMLS CUI [5,3])
C0022658 (UMLS CUI [6])
C0017163 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0035204 (UMLS CUI [8])
C0007222 (UMLS CUI [9])
C0151744 (UMLS CUI [10])
C0014130 (UMLS CUI [11])
C0027765 (UMLS CUI [12])
C0021053 (UMLS CUI [13])
C0018939 (UMLS CUI [14])
Seizures | Patient Etiology | Patient Resolved
Item
known history of seizures; however, a patient whose etiology is identifiable and has been resolved may be enrolled
boolean
C0036572 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1314792 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C3714811 (UMLS CUI [3,2])
Diabetes Mellitus | Complications of Diabetes Mellitus | Diabetes Mellitus potential | Blood glucose measurement Single | Fasting blood glucose measurement
Item
known history of diabetes mellitus, complications of diabetes mellitus, or potential diabetes mellitus as defined by patients with single blood glucose measurement based on site tests; patients with values greater than or equal to 140 mg/dl (non-fasting) or greater than or equal to 110 mg/dl (fasting) must be excluded from the study
boolean
C0011849 (UMLS CUI [1])
C0342257 (UMLS CUI [2])
C0011849 (UMLS CUI [3,1])
C3245505 (UMLS CUI [3,2])
C0392201 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
C0428568 (UMLS CUI [5])
Allergic Reaction olanzapine | intolerance to olanzapine
Item
history of allergic reaction or intolerance to olanzapine
boolean
C1527304 (UMLS CUI [1,1])
C0171023 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0171023 (UMLS CUI [2,2])
Psychostimulant | Reserpine
Item
have received treatment with psychostimulants or reserpine within 1 week prior to study drug administration
boolean
C0304403 (UMLS CUI [1])
C0035179 (UMLS CUI [2])
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