0 Evaluaciones
ID

36027

Descripción

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the concomitant medication form. It has to be filled in if the subject takes concomitant medication during the study trial. Please complete drug section for all drugs (including OTC)/ vaccines taken by mother within 3 months prior or during pregnancy.

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Versiones (1)
  1. 9/4/19 9/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de abril de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Inglés

    Concomitant Medication

    1 formularios  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject No.
    Descripción

    Subject No.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Descripción

    Panel ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    GSK Receipt Date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985846 (Receipt Date)
    Concomitant Medication
    Descripción

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Are there any concomitant medication CHANGES since the start of the study?
    Descripción

    If 'YES', please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Experiences Form, utilzing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2169461 (recent change in medication)
    DRUG NAME
    Descripción

    (Trade Name Preferred)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Single Dose/Unit
    Descripción

    Single Dose/Unit

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1960417 (Single dose characteristic)
    SNOMED
    426146003
    Frequency of this Dose
    Descripción

    Frequency of this Dose

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    Route
    Descripción

    Other routes may be entered onto the form when appropriate, and will be coded prior to data entry.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Indication
    Descripción

    Indication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Start Date
    Descripción

    day month year As a minimum the year must be stated.

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    Start Time
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C2826740 (Concomitant Medication Start Time)
    End Date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826744 (Concomitant Medication End Date)
    End Time or check the following item if medication is continuing.
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C2826659 (Concomitant Medication End Time)
    Continuing at end of study?
    Descripción

    Continuing at end of study

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1553904 (continuing therapy)
    UMLS CUI [1,2]
    C2983670 (Study End Date)
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    Similar models

    Concomitant Medication

    1 formularios
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    GSK Receipt Date
    Item
    GSK Receipt Date
    date
    C2985846 (UMLS CUI [1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant medication changes
    Item
    Are there any concomitant medication CHANGES since the start of the study?
    boolean
    C2347852 (UMLS CUI [1,1])
    C2169461 (UMLS CUI [1,2])
    DRUG NAME
    Item
    DRUG NAME
    text
    C2360065 (UMLS CUI [1])
    Single Dose/Unit
    Item
    Single Dose/Unit
    text
    C1960417 (UMLS CUI [1])
    Frequency of this Dose
    Item
    Frequency of this Dose
    text
    C3476109 (UMLS CUI [1])
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Route
    Code List
    Route
    CL Item
    intra-articular (IA)
    CL Item
    intra-arterial (IAR)
    CL Item
    intra-dermal (ID)
    CL Item
    inhalation (IH)
    CL Item
    intra-muscular (IM)
    CL Item
    intra-thecal (IT)
    CL Item
    intra-venous (IV)
    CL Item
    nasal (NA)
    CL Item
    oral (PO)
    CL Item
    rectal (PR)
    CL Item
    subcutaneous (SC)
    CL Item
    sub lingual (SL)
    CL Item
    transdermal (TD)
    CL Item
    topical (TO)
    CL Item
    vaginal (VA)
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Start Date
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1])
    Start Time
    Item
    Start Time
    time
    C2826740 (UMLS CUI [1])
    End Date
    Item
    End Date
    date
    C2826744 (UMLS CUI [1])
    End Time
    Item
    End Time or check the following item if medication is continuing.
    time
    C2826659 (UMLS CUI [1])
    Continuing at end of study
    Item
    Continuing at end of study?
    boolean
    C1553904 (UMLS CUI [1,1])
    C2983670 (UMLS CUI [1,2])
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