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ID

43832

Description

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

Lien

https://clinicaltrials.gov/show/NCT01457352

Mots-clés

Versions (2)
  1. 13/03/2016 13/03/2016 -
  2. 20/09/2021 20/09/2021 -
Téléchargé le

20 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Spasticity NCT01457352

    Anglais

    Eligibility Spasticity NCT01457352

    1 Formulaires  
    1. StudyEvent: Eligibility
      1. Eligibility Spasticity NCT01457352
    Inclusion Criteria
    Description

    Inclusion Criteria

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

    gender; age

    Type de données

    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)
    Description

    Fertility Female ; Contraception status; condoms

    Type de données

    boolean

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

    negative pregnancy test

    Type de données

    boolean

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

    spasticity; Multiple Sclerosis

    Type de données

    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)
    Description

    dosage baclofen

    Type de données

    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
    Description

    compliance

    Type de données

    boolean

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

    informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    history of hypersensitivity to baclofen
    Description

    hypersensitivity baclofen

    Type de données

    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
    Description

    disease relapse

    Type de données

    boolean

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

    concomitant disease neurologic

    Type de données

    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
    Description

    concomitant medication

    Type de données

    boolean

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

    compliance

    Type de données

    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
    Description

    major surgery

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    Retour au début de la page

    Similar models

    Eligibility Spasticity NCT01457352

    1 Formulaires
    1. StudyEvent: Eligibility
      1. Eligibility Spasticity NCT01457352
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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