0 Ratings
ID

30875

Description

This ODM file contains documentation of concomitant medications. To be checked for (and added if neccessary) at Screening, Sessions 1 and 2 (Day -1), Early Withdrawal and Follow-Up. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Keywords

Versions (2)
  1. 6/29/18 6/29/18 - Sarah Riepenhausen
  2. 6/29/18 6/29/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 29, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

    English

    Concomitant Medications

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Were any concomitant medications taken by the subject during the study?
    Description

    If Yes, record each medication in a separate set of the following questions of this itemgroup using Trade Names where possible.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    Drug Name
    Description

    Trade name preferred, e.g. Aspirin

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C2347852
    Unit Dose
    Description

    Unit Dose

    Data type

    float

    Alias
    UMLS CUI [1]
    C2826767
    Units
    Description

    Examples: Abbreviation = Label TAB = Tablet MCL = Microlitre ML = Millilitre L = Litre MCG = Microgram MG = Milligram G = Gram

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826646
    Frequency
    Description

    Examples: Abbreviation = Label OD/QD = 1 x Daily BID = 2 x Daily TID = 3 x Daily QID = 4 x Daily PRN = As required

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826654
    Route
    Description

    Examples: Abbreviation = Label IM = Intramuscular IH = Inhalation IV = Intravenous NS = Nasal TP = Topical PO = Oral VG = Vaginal

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826730
    Reason for Medication
    Description

    Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: Current Medical Conditions Non-Serious Adverse Events Serious Adverse Events Form

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696
    Start Date
    Description

    Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit. Record Unknown months as UNK

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734
    Start Time
    Description

    Start Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1301880
    Taken Prior to Study
    Description

    Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826667
    Stop Date
    Description

    Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744
    Stop Time
    Description

    Stop Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1522314
    Ongoing Medication?
    Description

    Ongoing Medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826666
    Back to the top of the page

    Similar models

    Concomitant Medications

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Item
    Were any concomitant medications taken by the subject during the study?
    text
    C2347852 (UMLS CUI [1])
    Planned relative Time
    Code List
    Were any concomitant medications taken by the subject during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Unit Dose
    Item
    Unit Dose
    float
    C2826767 (UMLS CUI [1])
    Units
    Item
    Units
    text
    C2826646 (UMLS CUI [1])
    Frequency
    Item
    Frequency
    text
    C2826654 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C2826730 (UMLS CUI [1])
    Reason for Medication
    Item
    Reason for Medication
    text
    C2826696 (UMLS CUI [1])
    Start Date Concomitant Medication
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1])
    Start Time
    Item
    Start Time
    time
    C2347852 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Item
    Taken Prior to Study
    text
    C2826667 (UMLS CUI [1])
    Taken Prior to Study
    Code List
    Taken Prior to Study
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Stop Date
    Item
    Stop Date
    date
    C2826744 (UMLS CUI [1])
    Stop Time
    Item
    Stop Time
    time
    C2347852 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Ongoing Medication?
    text
    C2826666 (UMLS CUI [1])
    Planned relative Time
    Code List
    Ongoing Medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Back to the top of the page 

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