ID

36087

Beskrivning

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 Drug Screening and Alcohol Breath Test for screening form. It has to be filled in for screening.

Nyckelord

Versioner (2)
  1. 2019-04-15 2019-04-15 -
  2. 2019-04-15 2019-04-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 april 2019

DOI

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Licens

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

    Engelsk

    Drug Screening and Alcohol Breath Test for screening

    1 Formulär  
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Beskrivning

    Subject No.:

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Beskrivning

    Panel ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Drug Screening
    Beskrivning

    Drug Screening

    Alias
    UMLS CUI-1
    C0373483
    Exact date of urine sampling
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0011008
    Exact time of urine sampling
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0040223
    Were there any contra-indicated drugs detected?
    Beskrivning

    If YES, please record all the relevant contra-indicated drugs below.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1511790
    UMLS CUI [1,2]
    C1444657
    UMLS CUI [1,3]
    C1254351
    Type of drug
    Beskrivning

    Type of drug

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0457591
    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Alcohol breath test
    Beskrivning

    Alcohol breath test

    Alias
    UMLS CUI-1
    C0202306
    Exact date of test
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C0011008
    Exact time of test
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C0429928
    Result of Alcohol breath test
    Beskrivning

    Alcohol breath test result, tick one If POSITIVE, do not include the subject in the study.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C1274040
    Tillbaka till toppen

    Similar models

    Drug Screening and Alcohol Breath Test for screening

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    Drug Screening
    C0373483 (UMLS CUI-1)
    Urine sampling date
    Item
    Exact date of urine sampling
    date
    C0200354 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Urine sampling time
    Item
    Exact time of urine sampling
    time
    C0042014 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Were there any contra-indicated drugs detected?
    text
    C1511790 (UMLS CUI [1,1])
    C1444657 (UMLS CUI [1,2])
    C1254351 (UMLS CUI [1,3])
    Contra-indicated drugs detected
    Code List
    Were there any contra-indicated drugs detected?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Type of drug
    Item
    Type of drug
    text
    C0457591 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Alcohol breath test
    C0202306 (UMLS CUI-1)
    Date of test
    Item
    Exact date of test
    date
    C0202306 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of test
    Item
    Exact time of test
    time
    C0202306 (UMLS CUI [1,1])
    C0429928 (UMLS CUI [1,2])
    Item
    Result of Alcohol breath test
    text
    C0202306 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result of Alcohol breath test
    Code List
    Result of Alcohol breath test
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Tillbaka till toppen 

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