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36911

Beschreibung

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 (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Unscheduled measurements form. It includes: Laboratory, Drug Screening, Vital Signs, 12 Lead ECG and General comments. It has to be filled in if required.

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Versionen (2)
  1. 05/09/2017 05/09/2017 -
  2. 21/06/2019 21/06/2019 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

21 juin 2019

DOI

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

    Englisch

    Unscheduled measurements

    1 Formulare  
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beschreibung

    Subject number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Clinical chemistry and haematology
    Beschreibung

    Clinical chemistry and haematology

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0018941
    Date of blood sampling
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0005834
    Time of blood sampling
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0005834
    Comments:
    Beschreibung

    Comments

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    Beschreibung

    If ‘Yes’, please record diagnosis on Adverse Event page.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0005834
    Urinalysis
    Beschreibung

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Date of urine sampling
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0200354
    Time of urine sampling
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200354
    Comments:
    Beschreibung

    Comments

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    Beschreibung

    laboratory findings urinalysis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0042014
    Drug Screening (Urine)
    Beschreibung

    Drug Screening (Urine)

    Alias
    UMLS CUI-1
    C0202274
    Date of urine sampling
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0200354
    Time of urine sampling
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200354
    Were there any contra-indicated drugs detected?
    Beschreibung

    If ‘Yes’, please record all the relevant contra-indicated drugs below.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3845816
    Type of drug
    Beschreibung

    Type of drug

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0457591
    Comments
    Beschreibung

    Comments

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Vital signs
    Beschreibung

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Study day
    Beschreibung

    Study day

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2826182
    Study time
    Beschreibung

    Study time

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C0040223
    Position at measurement
    Beschreibung

    Position at measurement

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2963216
    UMLS CUI [1,2]
    C1262869
    Date of measurement
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Time of measurement
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Systolic blood pressure
    Beschreibung

    Systolic blood pressure

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic blood pressure
    Beschreibung

    Diastolic blood pressure

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschreibung

    Pulse

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    Heart rate
    Beschreibung

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    12 Lead ECG
    Beschreibung

    12 Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Study day
    Beschreibung

    Study day

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2826182
    Study time
    Beschreibung

    Study time

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C0040223
    Date of measurement
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Time of measurement
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Heart rate
    Beschreibung

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    PR
    Beschreibung

    PR

    Datentyp

    integer

    Maßeinheiten
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS
    Beschreibung

    QRS

    Datentyp

    integer

    Maßeinheiten
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    QT
    Beschreibung

    QT

    Datentyp

    integer

    Maßeinheiten
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTc
    Beschreibung

    QTc

    Datentyp

    integer

    Maßeinheiten
    • msec
    Alias
    UMLS CUI [1]
    C0489625
    msec
    ECG normal?
    Beschreibung

    ECG normal

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Beschreibung

    Comments

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    General Comments
    Beschreibung

    General Comments

    Alias
    UMLS CUI-1
    C0947611
    General Comments
    Beschreibung

    General Comments

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Unscheduled measurements

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Clinical chemistry and haematology
    C0008000 (UMLS CUI-1)
    C0018941 (UMLS CUI-2)
    Date of blood sampling
    Item
    Date of blood sampling
    date
    C0011008 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Time of blood sampling
    Item
    Time of blood sampling
    time
    C0040223 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Comments
    Item
    Comments:
    text
    C0947611 (UMLS CUI [1])
    Item
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    text
    C0022877 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    laboratory findings blood sampling
    Code List
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Urinalysis
    C0042014 (UMLS CUI-1)
    Date of urine sampling
    Item
    Date of urine sampling
    date
    C0011008 (UMLS CUI [1,1])
    C0200354 (UMLS CUI [1,2])
    Time of urine sampling
    Item
    Time of urine sampling
    time
    C0040223 (UMLS CUI [1,1])
    C0200354 (UMLS CUI [1,2])
    Comments
    Item
    Comments:
    text
    C0947611 (UMLS CUI [1])
    laboratory findings urinalysis
    Item
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    boolean
    C0022877 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    Item Group
    Drug Screening (Urine)
    C0202274 (UMLS CUI-1)
    Date of urine sampling
    Item
    Date of urine sampling
    date
    C0011008 (UMLS CUI [1,1])
    C0200354 (UMLS CUI [1,2])
    Time of urine sampling
    Item
    Time of urine sampling
    time
    C0040223 (UMLS CUI [1,1])
    C0200354 (UMLS CUI [1,2])
    Item
    Were there any contra-indicated drugs detected?
    text
    C3845816 (UMLS CUI [1])
    Contraindicated drugs
    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])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Study day
    Item
    Study day
    integer
    C2826182 (UMLS CUI [1])
    Study time
    Item
    Study time
    integer
    C2348563 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Position at measurement
    integer
    C2963216 (UMLS CUI [1,1])
    C1262869 (UMLS CUI [1,2])
    Position at measurement
    Code List
    Position at measurement
    CL Item
    Supine (1)
    CL Item
    Standing (2)
    Date of measurement
    Item
    Date of measurement
    date
    C0011008 (UMLS CUI [1])
    Time of measurement
    Item
    Time of measurement
    time
    C0040223 (UMLS CUI [1])
    Systolic blood pressure
    Item
    Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    12 Lead ECG
    C0430456 (UMLS CUI-1)
    Study day
    Item
    Study day
    integer
    C2826182 (UMLS CUI [1])
    Study time
    Item
    Study time
    integer
    C2348563 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Date of measurement
    Item
    Date of measurement
    date
    C0011008 (UMLS CUI [1])
    Time of measurement
    Item
    Time of measurement
    time
    C0040223 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR
    Item
    PR
    integer
    C0429087 (UMLS CUI [1])
    QRS
    Item
    QRS
    integer
    C0429025 (UMLS CUI [1])
    QT
    Item
    QT
    integer
    C1287082 (UMLS CUI [1])
    QTc
    Item
    QTc
    integer
    C0489625 (UMLS CUI [1])
    Item
    ECG normal?
    text
    C0522054 (UMLS CUI [1])
    ECG normal
    Code List
    ECG normal?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item Group
    General Comments
    C0947611 (UMLS CUI-1)
    General Comments
    Item
    General Comments
    text
    C0947611 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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