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ID

36085

Beschrijving

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (Day 0) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (Day 21) This document contains the prior medication form. It has to be filled in for screening.

Trefwoorden

Versies (3)
  1. 15-04-19 15-04-19 -
  2. 15-04-19 15-04-19 -
  3. 20-09-21 20-09-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 april 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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    Determination of starting dose and up-titration regimen for a new formulation of Ropinirole, 101468/201

    Engels

    Prior Medication

    1 Formulieren  
    1. StudyEvent: ODM
      1. Prior Medication
    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Beschrijving

    Subject No.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Beschrijving

    Panel ID

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit Date
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Prior Medication
    Beschrijving

    Prior Medication

    Alias
    UMLS CUI-1
    C2826257
    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    Beschrijving

    If 'YES', please record the medications below.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3166216
    UMLS CUI [2]
    C0013231
    DRUG NAME
    Beschrijving

    (Trade Name Preferred)

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2360065
    Single Dose/Unit (e.g.500 mg)
    Beschrijving

    Single Dose/Unit

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1960417
    Frequency of this Dose (e.g.BID, PR)
    Beschrijving

    Frequency of this Dose

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Beschrijving

    Route

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0013153
    Indication
    Beschrijving

    Indication

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0013227
    Duration of therapy (e.g.6 years)
    Beschrijving

    Duration of therapy

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0444917
    End Date
    Beschrijving

    Day/Month/Year

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Continuing at end of study?
    Beschrijving

    Continuing at end of study

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1553904
    UMLS CUI [1,2]
    C2983670
    Terug naar het begin van de pagina

    Similar models

    Prior Medication

    1 Formulieren
    1. StudyEvent: ODM
      1. Prior Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Prior Medication
    C2826257 (UMLS CUI-1)
    Prescribed or OTC medication
    Item
    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    boolean
    C3166216 (UMLS CUI [1])
    C0013231 (UMLS CUI [2])
    DRUG NAME
    Item
    DRUG NAME
    text
    C2360065 (UMLS CUI [1])
    Single Dose/Unit
    Item
    Single Dose/Unit (e.g.500 mg)
    text
    C1960417 (UMLS CUI [1])
    Frequency of this Dose
    Item
    Frequency of this Dose (e.g.BID, PR)
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Duration of therapy
    Item
    Duration of therapy (e.g.6 years)
    text
    C0444917 (UMLS CUI [1])
    End Date
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Continuing at end of study
    Item
    Continuing at end of study?
    boolean
    C1553904 (UMLS CUI [1,1])
    C2983670 (UMLS CUI [1,2])
    Terug naar het begin van de pagina 

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