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ID

43832

Descrizione

Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01457352

collegamento

https://clinicaltrials.gov/show/NCT01457352

Keywords

versioni (2)
  1. 13/03/16 13/03/16 -
  2. 20/09/21 20/09/21 -
Caricato su

20 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility Spasticity NCT01457352

    Inglese

    Eligibility Spasticity NCT01457352

    1 moduli  
    1. StudyEvent: Eligibility
      1. Eligibility Spasticity NCT01457352
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    men and women age 18 years and older
    Descrizione

    gender; age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    women of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (iud), oral or long acting injected contraceptives, bilateral tubal ligation or vasectomized partner] for at least 3 months prior to study entry or postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy)
    Descrizione

    Fertility Female ; Contraception status; condoms

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0015895
    UMLS CUI [2]
    C0086287
    UMLS CUI [3]
    C0677582
    if female, negative pregnancy test
    Descrizione

    negative pregnancy test

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0427780
    known history of spasticity due to ms prior to starting baclofen
    Descrizione

    spasticity; Multiple Sclerosis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0026838
    UMLS CUI [2]
    C0026769
    a stable daily dose of baclofen ir, ranging from 30 to 60 mg/day (i.e., same dose given in the same schedule for last 30 days)
    Descrizione

    dosage baclofen

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0004609
    able and willing to comply with the protocol, including availability for a scheduled clinic visits
    Descrizione

    compliance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    willingness and giving of written informed consent
    Descrizione

    informed consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    history of hypersensitivity to baclofen
    Descrizione

    hypersensitivity baclofen

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0004609
    in relapse or history of unstable course over the prior 30 days prior to the screening visit
    Descrizione

    disease relapse

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    concomitant neurologic conditions causing spasticity
    Descrizione

    concomitant disease neurologic

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0243087
    UMLS CUI [1,2]
    C0205494
    has received an investigational drug or device within 30 days that would interfere with the study goals prior to the screening visit
    Descrizione

    concomitant medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    unable to comply with study procedures in the opinion of the investigator
    Descrizione

    compliance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    has had major surgery within 3 months prior to screening visit that may affect spasticity assessments such as abdominal surgery, back surgery, or lower leg or knee surgeries
    Descrizione

    major surgery

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    Ritorna all'inizio della pagina

    Similar models

    Eligibility Spasticity NCT01457352

    1 moduli
    1. StudyEvent: Eligibility
      1. Eligibility Spasticity NCT01457352
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    gender; age
    Item
    men and women age 18 years and older
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Fertility Female ; Contraception status; condoms
    Item
    women of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (iud), oral or long acting injected contraceptives, bilateral tubal ligation or vasectomized partner] for at least 3 months prior to study entry or postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy)
    boolean
    C0015895 (UMLS CUI [1])
    C0086287 (UMLS CUI [2])
    C0677582 (UMLS CUI [3])
    negative pregnancy test
    Item
    if female, negative pregnancy test
    boolean
    C0427780 (UMLS CUI [1])
    spasticity; Multiple Sclerosis
    Item
    known history of spasticity due to ms prior to starting baclofen
    boolean
    C0026838 (UMLS CUI [1])
    C0026769 (UMLS CUI [2])
    dosage baclofen
    Item
    a stable daily dose of baclofen ir, ranging from 30 to 60 mg/day (i.e., same dose given in the same schedule for last 30 days)
    boolean
    C0178602 (UMLS CUI [1,1])
    C0004609 (UMLS CUI [1,2])
    compliance
    Item
    able and willing to comply with the protocol, including availability for a scheduled clinic visits
    boolean
    C1321605 (UMLS CUI [1])
    informed consent
    Item
    willingness and giving of written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    hypersensitivity baclofen
    Item
    history of hypersensitivity to baclofen
    boolean
    C0020517 (UMLS CUI [1,1])
    C0004609 (UMLS CUI [1,2])
    disease relapse
    Item
    in relapse or history of unstable course over the prior 30 days prior to the screening visit
    boolean
    C0277556 (UMLS CUI [1])
    concomitant disease neurologic
    Item
    concomitant neurologic conditions causing spasticity
    boolean
    C0243087 (UMLS CUI [1,1])
    C0205494 (UMLS CUI [1,2])
    concomitant medication
    Item
    has received an investigational drug or device within 30 days that would interfere with the study goals prior to the screening visit
    boolean
    C2347852 (UMLS CUI [1])
    compliance
    Item
    unable to comply with study procedures in the opinion of the investigator
    boolean
    C1321605 (UMLS CUI [1])
    major surgery
    Item
    has had major surgery within 3 months prior to screening visit that may affect spasticity assessments such as abdominal surgery, back surgery, or lower leg or knee surgeries
    boolean
    C0679637 (UMLS CUI [1])
    Ritorna all'inizio della pagina 

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