ID

14614

Descrizione

Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months; ODM derived from: https://clinicaltrials.gov/show/NCT00200512

collegamento

https://clinicaltrials.gov/show/NCT00200512

Keywords

versioni (1)
  1. 24/04/16 24/04/16 -
Caricato su

24 aprile 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility Parkinson Disease NCT00200512

    Inglese

    Eligibility Parkinson Disease NCT00200512

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients diagnosed with idiopathic parkinson's disease and classified as stage ii-iv of the hoehn and yahr scale for staging the severity of parkinson's disease
    Descrizione

    Parkinson's disease and hoehn and yahr scale

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0030567
    UMLS CUI [2]
    C0451215
    patients must have been on an optimally maximized oral therapy regimen including levodopa/decarboxylase inhibitors in either immediate or delayed release forms, plus at least one direct acting oral dopamine agonist for at least 30 days prior to randomization
    Descrizione

    Pharmacotherapy regimen

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023570
    UMLS CUI [2]
    C0360140
    UMLS CUI [3]
    C0178601
    patients must have been receiving apomorphine subcutaneous injections for rescue therapy for "off" events for at least three months with an average dosing requirement of at least 2 doses per day over the week prior to enrollment with a dose of less than 11 mg
    Descrizione

    Apomorphine subcutaneous injections dosage

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0003596
    UMLS CUI [1,2]
    C0178602
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of antiparkinson medications. (patients with hallucinations or other central adverse reactions associated solely with antiparkinson medications were not excluded.)
    Descrizione

    Medical therapy for psychoses or dementia

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0418981
    UMLS CUI [1,2]
    C0033975
    UMLS CUI [2,1]
    C0418981
    UMLS CUI [2,2]
    C0497327
    patients with a history of drug or alcohol dependency within one year prior to study enrollment
    Descrizione

    Substance use disorder

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    patients with unstable and clinically significant disease of cardiovascular (including orthostatic hypotension), hematologic (including coombs' positive hemolytic anemia), hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems or neoplasm within the threemonths before the start of the study.
    Descrizione

    Comorbidity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    patients with a history of allergy or intolerance to morphine or its derivatives, sulfur, sulfur containing medication, sulfites, domperidone, trimethobenzamide or other anticholinergics.
    Descrizione

    Allergy to pharmacotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013216
    patients treated with experimental agents (other than apomorphine intermittent subcutaneous injections) within 3 months before study entry, experimental agents were defined on the basis of the regulatory status in the country of patient observation, or with other disallowed medications
    Descrizione

    Experimental drug

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0304229
    patients whose apomorphine regimen was characterized by continuous infusion or by administration methods other than intermittent subcutaneous injection.
    Descrizione

    Apomorphine regimen

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0003596
    UMLS CUI [1,2]
    C0040808
    patients who could not or would not sign an informed consent form.
    Descrizione

    Informed consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
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    Similar models

    Eligibility Parkinson Disease NCT00200512

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Parkinson's disease and hoehn and yahr scale
    Item
    patients diagnosed with idiopathic parkinson's disease and classified as stage ii-iv of the hoehn and yahr scale for staging the severity of parkinson's disease
    boolean
    C0030567 (UMLS CUI [1])
    C0451215 (UMLS CUI [2])
    Pharmacotherapy regimen
    Item
    patients must have been on an optimally maximized oral therapy regimen including levodopa/decarboxylase inhibitors in either immediate or delayed release forms, plus at least one direct acting oral dopamine agonist for at least 30 days prior to randomization
    boolean
    C0023570 (UMLS CUI [1])
    C0360140 (UMLS CUI [2])
    C0178601 (UMLS CUI [3])
    Apomorphine subcutaneous injections dosage
    Item
    patients must have been receiving apomorphine subcutaneous injections for rescue therapy for "off" events for at least three months with an average dosing requirement of at least 2 doses per day over the week prior to enrollment with a dose of less than 11 mg
    boolean
    C0003596 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Medical therapy for psychoses or dementia
    Item
    patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of antiparkinson medications. (patients with hallucinations or other central adverse reactions associated solely with antiparkinson medications were not excluded.)
    boolean
    C0418981 (UMLS CUI [1,1])
    C0033975 (UMLS CUI [1,2])
    C0418981 (UMLS CUI [2,1])
    C0497327 (UMLS CUI [2,2])
    Substance use disorder
    Item
    patients with a history of drug or alcohol dependency within one year prior to study enrollment
    boolean
    C0038586 (UMLS CUI [1])
    Comorbidity
    Item
    patients with unstable and clinically significant disease of cardiovascular (including orthostatic hypotension), hematologic (including coombs' positive hemolytic anemia), hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems or neoplasm within the threemonths before the start of the study.
    boolean
    C0009488 (UMLS CUI [1])
    Allergy to pharmacotherapy
    Item
    patients with a history of allergy or intolerance to morphine or its derivatives, sulfur, sulfur containing medication, sulfites, domperidone, trimethobenzamide or other anticholinergics.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    Experimental drug
    Item
    patients treated with experimental agents (other than apomorphine intermittent subcutaneous injections) within 3 months before study entry, experimental agents were defined on the basis of the regulatory status in the country of patient observation, or with other disallowed medications
    boolean
    C0304229 (UMLS CUI [1])
    Apomorphine regimen
    Item
    patients whose apomorphine regimen was characterized by continuous infusion or by administration methods other than intermittent subcutaneous injection.
    boolean
    C0003596 (UMLS CUI [1,1])
    C0040808 (UMLS CUI [1,2])
    Informed consent
    Item
    patients who could not or would not sign an informed consent form.
    boolean
    C0021430 (UMLS CUI [1])
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