ID

23095

Beschreibung

A Comparison of the Pharmacokinetics and Safety of Long-acting Injectable Risperidone When Administered to Gluteal or Deltoid Intramuscular Injection Sites in Stable Schizophrenia Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT00843687

Link

https://clinicaltrials.gov/show/NCT00843687

Stichworte

  1. 23.06.17 23.06.17 -
Hochgeladen am

23. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT00843687

Eligibility Schizophrenia NCT00843687

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic schizophrenia of any subtype, according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria
Beschreibung

Chronic schizophrenia Subtype Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221765
UMLS CUI [1,2]
C0449560
UMLS CUI [1,3]
C1552551
stable schizophrenia without any changes in medications or dosage during the 4 weeks before the screening visit
Beschreibung

Schizophrenia Stable | Pharmaceutical Preparations unchanged | Pharmaceutical Preparations Dosage unchanged

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0442739
clinical global impression scale score of <=3 (mild)
Beschreibung

Clinical Global Impression Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1]
C3639708
informed consent signed by the patient
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
Beschreibung

Healthy Volunteer | Physical Examination Pre-study | Medical History

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C1527048
UMLS CUI [3]
C0262926
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
no dsm-iv axis i diagnosis other than schizophrenia
Beschreibung

Axis I diagnosis | Schizophrenia Excluded

Datentyp

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C2828389
no pregnant or breast feeding women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
no female subject of childbearing potential without adequate contraception
Beschreibung

Childbearing Potential Contraceptive methods Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
no history of severe drug allergy or hypersensitivity
Beschreibung

Drug Allergy Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205082
no patients with inadequate mass in the gluteal or deltoid regions to receive the intramuscular drug injections.
Beschreibung

Intramuscular injection | Gluteal Region Mass Inadequate | Deltoid region Mass Inadequate

Datentyp

boolean

Alias
UMLS CUI [1]
C0021492
UMLS CUI [2,1]
C0282082
UMLS CUI [2,2]
C0577573
UMLS CUI [2,3]
C0205412
UMLS CUI [3,1]
C0230339
UMLS CUI [3,2]
C0577573
UMLS CUI [3,3]
C0205412

Ähnliche Modelle

Eligibility Schizophrenia NCT00843687

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic schizophrenia Subtype Any
Item
chronic schizophrenia of any subtype, according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria
boolean
C0221765 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Schizophrenia Stable | Pharmaceutical Preparations unchanged | Pharmaceutical Preparations Dosage unchanged
Item
stable schizophrenia without any changes in medications or dosage during the 4 weeks before the screening visit
boolean
C0036341 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
Clinical Global Impression Questionnaire
Item
clinical global impression scale score of <=3 (mild)
boolean
C3639708 (UMLS CUI [1])
Informed Consent
Item
informed consent signed by the patient
boolean
C0021430 (UMLS CUI [1])
Healthy Volunteer | Physical Examination Pre-study | Medical History
Item
patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
boolean
C1708335 (UMLS CUI [1])
C0031809 (UMLS CUI [2,1])
C1527048 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Schizophrenia Excluded
Item
no dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
no pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Lacking
Item
no female subject of childbearing potential without adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Drug Allergy Severe
Item
no history of severe drug allergy or hypersensitivity
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Intramuscular injection | Gluteal Region Mass Inadequate | Deltoid region Mass Inadequate
Item
no patients with inadequate mass in the gluteal or deltoid regions to receive the intramuscular drug injections.
boolean
C0021492 (UMLS CUI [1])
C0282082 (UMLS CUI [2,1])
C0577573 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0230339 (UMLS CUI [3,1])
C0577573 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])

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