0 Ratings
ID

30496

Description

This ODM file contains the Appetite VAS and Distress VAS. Appetite VAS to be done at Screening, Sessions 1 and 2 (Day 1, pre-dose and 2 hrs post-dose), Distress VAS to be done at Sessions 1 and 2 (Day 1, pre-dose, 2, 4 and 10 hrs post-dose). 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 (1)
  1. 6/8/18 6/8/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 8, 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

    Appetite and Distress VAS (Screening, Sessions 1 and 2)

    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
    Type of Visit
    Description

    Visit

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082
    Appetite VAS
    Description

    Appetite VAS

    Alias
    UMLS CUI-1
    C0003618
    UMLS CUI-2
    C3536884
    Date of assessment
    Description

    Date of assessment

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C0003618
    UMLS CUI [1,3]
    C3536884
    Relative Time on Session Visits
    Description

    Item not to be used at screening Visit.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0003618
    UMLS CUI [1,2]
    C3536884
    UMLS CUI [1,3]
    C1516048
    UMLS CUI [1,4]
    C0439564
    Time of Assessment
    Description

    Time of Assessment

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0003618
    UMLS CUI [1,2]
    C3536884
    UMLS CUI [1,3]
    C1516048
    UMLS CUI [1,4]
    C0040223
    How hungry are you feeling?
    Description

    Result from the VAS: mm from left end of scale 0 mm -> not feeling any hunger 100 mm -> feeling the hungriest ever felt

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0849960
    mm
    How full do you feel?
    Description

    Result from the VAS: mm from left end of scale 0 mm -> Feeling very full 100 mm -> not feeling full at all

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C1286349
    mm
    How much do you crave fatty or sugary foods?
    Description

    Result from the VAS: mm from left end of scale 0 mm -> not craving those foods at all 100 mm -> craving those foods very much

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0241314
    UMLS CUI [2,1]
    C0872380
    UMLS CUI [2,2]
    C0453819
    mm
    Distress VAS
    Description

    Distress VAS

    Alias
    UMLS CUI-1
    C3536884
    UMLS CUI-2
    C0231303
    Date of Assessment
    Description

    Not neccessary on Screening visit.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3536884
    UMLS CUI [1,2]
    C0231303
    UMLS CUI [1,3]
    C2985720
    Time of Assessment
    Description

    Not neccessary on Screening visit.

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C3536884
    UMLS CUI [1,2]
    C0231303
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [1,4]
    C1516048
    Relative Time on Session Visits
    Description

    Not to be filled at screening visit.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3536884
    UMLS CUI [1,2]
    C0231303
    UMLS CUI [1,3]
    C0439564
    UMLS CUI [1,4]
    C1516048
    How distressed do you feel at the present time?
    Description

    VAS: Mark a single line that crosses at the point of the given line that represents how you feel at the present time. 0mm: No distress 100mm: Maximum distress Not neccessary on Screening visit.

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0231303
    UMLS CUI [1,2]
    C0441889
    mm
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    Similar models

    Appetite and Distress VAS (Screening, Sessions 1 and 2)

    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
    Type of Visit
    text
    C0545082 (UMLS CUI [1])
    Visit
    Code List
    Type of Visit
    CL Item
    Screening (Screening)
    CL Item
    Session 1 (Session 1)
    CL Item
    Session 2 (Session 2)
    Item Group
    Appetite VAS
    C0003618 (UMLS CUI-1)
    C3536884 (UMLS CUI-2)
    Date of assessment
    Item
    Date of assessment
    date
    C2985720 (UMLS CUI [1,1])
    C0003618 (UMLS CUI [1,2])
    C3536884 (UMLS CUI [1,3])
    Item
    Relative Time on Session Visits
    text
    C0003618 (UMLS CUI [1,1])
    C3536884 (UMLS CUI [1,2])
    C1516048 (UMLS CUI [1,3])
    C0439564 (UMLS CUI [1,4])
    Relative Time of Assessment
    Code List
    Relative Time on Session Visits
    CL Item
    pre-dose (Day 1) (pre-dose (Day 1))
    CL Item
    2 hrs post-dose (Day 1) (2 hrs post-dose (Day 1))
    Time of Assessment
    Item
    Time of Assessment
    time
    C0003618 (UMLS CUI [1,1])
    C3536884 (UMLS CUI [1,2])
    C1516048 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Hungry
    Item
    How hungry are you feeling?
    float
    C0849960 (UMLS CUI [1])
    Fullness
    Item
    How full do you feel?
    float
    C1286349 (UMLS CUI [1])
    Craving for fatty or sugary foods
    Item
    How much do you crave fatty or sugary foods?
    float
    C0241314 (UMLS CUI [1])
    C0872380 (UMLS CUI [2,1])
    C0453819 (UMLS CUI [2,2])
    Item Group
    Distress VAS
    C3536884 (UMLS CUI-1)
    C0231303 (UMLS CUI-2)
    Date of Assessment
    Item
    Date of Assessment
    date
    C3536884 (UMLS CUI [1,1])
    C0231303 (UMLS CUI [1,2])
    C2985720 (UMLS CUI [1,3])
    Time of Assessment
    Item
    Time of Assessment
    time
    C3536884 (UMLS CUI [1,1])
    C0231303 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C1516048 (UMLS CUI [1,4])
    Item
    Relative Time on Session Visits
    text
    C3536884 (UMLS CUI [1,1])
    C0231303 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    C1516048 (UMLS CUI [1,4])
    Relative Time
    Code List
    Relative Time on Session Visits
    CL Item
    pre-dose (Day 1) (pre-dose (Day 1))
    CL Item
    2 hrs post-dose (Day 1) (2 hrs post-dose (Day 1))
    CL Item
    4 hrs post-dose (Day 1) (4 hrs post-dose (Day 1))
    CL Item
    10 hrs post-dose (Day 1) (10 hrs post-dose (Day 1))
    Distress level
    Item
    How distressed do you feel at the present time?
    float
    C0231303 (UMLS CUI [1,1])
    C0441889 (UMLS CUI [1,2])
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