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ID

36027

Description

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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Versions (1)
  1. 09/04/2019 09/04/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 avril 2019

DOI

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Licence

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

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    Concomitant Medication

    1 Formulaires  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Description

    Subject No.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Description

    Panel ID

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3846158
    GSK Receipt Date
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2985846
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Are there any concomitant medication CHANGES since the start of the study?
    Description

    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.

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2169461
    DRUG NAME
    Description

    (Trade Name Preferred)

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2360065
    Single Dose/Unit
    Description

    Single Dose/Unit

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1960417
    Frequency of this Dose
    Description

    Frequency of this Dose

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0013153
    Indication
    Description

    Indication

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0013227
    Start Date
    Description

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

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2826734
    Start Time
    Description

    00:00-23:59

    Type de données

    time

    Alias
    UMLS CUI [1]
    C2826740
    End Date
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2826744
    End Time or check the following item if medication is continuing.
    Description

    00:00-23:59

    Type de données

    time

    Alias
    UMLS CUI [1]
    C2826659
    Continuing at end of study?
    Description

    Continuing at end of study

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1553904
    UMLS CUI [1,2]
    C2983670
    Retour au début de la page

    Similar models

    Concomitant Medication

    1 Formulaires
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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