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42598

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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 Significant Medical/ Surgical History And Physical Examination and the Prior Medication form. It has to be filled in for screening.

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versioni (4)
  1. 01-09-17 01-09-17 -
  2. 18-06-19 18-06-19 -
  3. 18-06-19 18-06-19 -
  4. 17-09-21 17-09-21 -
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GlaxoSmithKline

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17 september 2021

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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

    Inglese

    Significant Medical/ Surgical History And Physical Examination, Prior Medication

    1 moduli  
    Administrative Data
    Descrizione

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Volunteer panel number
    Descrizione

    Volunteer panel number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1300638
    Subject number
    Descrizione

    Subject number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Significant Medical/ Surgical History And Physical Examination
    Descrizione

    Significant Medical/ Surgical History And Physical Examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
    Descrizione

    If you tick Yes, fill in the follwoing items for each diagnosis. Only in the absence of a diagnosis, record the signs and symptoms on separate lines.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1699700
    UMLS CUI [2]
    C0543467
    Diagnosis
    Descrizione

    Diagnosis

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0011900
    Year of first diagnosis
    Descrizione

    Month Year

    Tipo di dati

    partialDate

    Alias
    UMLS CUI [1,1]
    C0439234
    UMLS CUI [1,2]
    C0011900
    Medical condition
    Descrizione

    Medical condition

    Tipo di dati

    text

    Prior Medication
    Descrizione

    Prior Medication

    Alias
    UMLS CUI-1
    C2826257
    Has the subject taken any medication within 2 weeks prior to the study?
    Descrizione

    If you tick ‘Yes’, please record each medication in the following items.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826257
    Drug Name
    Descrizione

    (Trade name preferred)

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2360065
    Single dose
    Descrizione

    (eg 500 mg)

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1960417
    Frequency of this dose
    Descrizione

    (eg BID, PRN)

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C3476109
    Medication Route
    Descrizione

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

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0013153
    Indication of medication
    Descrizione

    Indication on Prior Medication page must correlate utilizing the same terminology. Indication on Concomitant page must be recorded on the Adverse Events Page and expressed utilizing the same terminology.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0013227
    Duration of therapy
    Descrizione

    (e.g. 6 years)

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0444921
    End date of therapy/medication
    Descrizione

    day month year. If therapy/medication is continuing tick the follwing item.

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0806020
    Continuing at end of study?
    Descrizione

    If a medication was marked continuing at the initial visit (on the Prior and Concomitant Medication Page), but has since had a dosage change or has been stopped, it must be recorded on this form as a change with the start and end date.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1553904
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    Similar models

    Significant Medical/ Surgical History And Physical Examination, Prior Medication

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Volunteer panel number
    Item
    Volunteer panel number
    integer
    C1300638 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Significant Medical/ Surgical History And Physical Examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Item
    Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
    text
    C1699700 (UMLS CUI [1])
    C0543467 (UMLS CUI [2])
    medical condition; surgery
    Code List
    Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Year of diagnosis
    Item
    Year of first diagnosis
    partialDate
    C0439234 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Item
    Medical condition
    text
    medical condition
    Code List
    Medical condition
    CL Item
    Past (Past)
    CL Item
    Ongoing (Ongoing)
    Item Group
    Prior Medication
    C2826257 (UMLS CUI-1)
    Item
    Has the subject taken any medication within 2 weeks prior to the study?
    text
    C2826257 (UMLS CUI [1])
    Prior Medication
    Code List
    Has the subject taken any medication within 2 weeks prior to the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    Single dose
    Item
    Single dose
    text
    C1960417 (UMLS CUI [1])
    Medication frequency
    Item
    Frequency of this dose
    text
    C3476109 (UMLS CUI [1])
    Item
    Medication Route
    text
    C0013153 (UMLS CUI [1])
    Medication Route
    Code List
    Medication 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
    sublingual (SL)
    CL Item
    transdermal (TD)
    CL Item
    topical (TO)
    CL Item
    vaginal (VA)
    Indication of medication
    Item
    Indication of medication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Duration of therapy
    Item
    Duration of therapy
    text
    C0444921 (UMLS CUI [1])
    End date of therapy/medication
    Item
    End date of therapy/medication
    date
    C0087111 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [2,1])
    C0806020 (UMLS CUI [2,2])
    Item
    Continuing at end of study?
    text
    C1553904 (UMLS CUI [1])
    Continuing therapy
    Code List
    Continuing at end of study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
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