0 Ratings
ID

30487

Description

This ODM file contains Vital Signs. To be filled on Screening, Session 1 + 2 (one half Day -1, one half 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 (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

    Vital Signs (All Visits)

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Visit Type
    Description

    This form has to be filled in at each attended visit mentioned in this item. On Session Visits the Body Measure Part is filled in on Day -1, the Rest on Day 1 (multiple time points).

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Vital Signs - Body Measures
    Description

    Vital Signs - Body Measures

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI-2
    C0203910 (Body measure procedure)
    SNOMED
    54709006
    Height
    Description

    Only mandatory at screening visit.

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Body Mass Index
    Description

    Only mandatory at screening visit.

    Data type

    float

    Measurement units
    • kg/m^2
    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    kg/m^2
    Hip Circumference
    Description

    Hip Circumference

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0562350 (Hip circumference)
    SNOMED
    284472007
    cm
    Waist Circumference
    Description

    Waist Circumference

    Data type

    float

    Alias
    UMLS CUI [1]
    C0455829 (Waist Circumference)
    SNOMED
    276361009
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Date
    Description

    On Session Visits not identical with date stated in administrative part of this form.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Planned relative Time
    Description

    Planned relative Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    Actual Time
    Description

    Actual Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Subject Position
    Description

    For each scheduled Planned Relative Time the measurements should first be done in semi-supine (4), then in standing (3) position.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C1262869 (Body position)
    SNOMED
    397155001
    LOINC
    LP120681-4
    Heart Rate
    Description

    Heart Rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    °C
    Location of Temperature Measurement
    Description

    Location of Temperature Measurement

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0489453 (Body temperature measurement site)
    LOINC
    LP72178-4
    Respiration rate
    Description

    Respiration rate

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832 (Respiratory rate)
    SNOMED
    86290005
    LOINC
    LP20159-7
    breaths/min
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    Similar models

    Vital Signs (All Visits)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Item
    Visit Type
    text
    C0545082 (UMLS CUI [1])
    Visit
    Code List
    Visit Type
    CL Item
    Screening (Screening)
    CL Item
    Session 1 (Session 1)
    CL Item
    Session 2 (Session 2)
    CL Item
    Early Withdrawal (Early Withdrawal)
    CL Item
    Follow-Up (Follow-Up)
    CL Item
    Unscheduled (Unscheduled)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Vital Signs - Body Measures
    C0518766 (UMLS CUI-1)
    C0203910 (UMLS CUI-2)
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body Mass Index
    Item
    Body Mass Index
    float
    C1305855 (UMLS CUI [1])
    Hip Circumference
    Item
    Hip Circumference
    integer
    C0562350 (UMLS CUI [1])
    Waist Circumference
    Item
    Waist Circumference
    float
    C0455829 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date of Measurement
    Item
    Date
    date
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Planned relative Time
    text
    C0518766 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned relative Time
    Code List
    Planned relative Time
    CL Item
    Screening (Screening)
    CL Item
    Unscheduled (Unscheduled)
    CL Item
    Pre-dose (Sessions Day 1) (Pre-dose (Sessions Day 1))
    CL Item
    0,5 hrs (Sessions Day 1) (0,5 hrs (Sessions Day 1))
    CL Item
    2 hrs (Sessions Day 1) (2 hrs (Sessions Day 1))
    CL Item
    5 hrs (Sessions Day 1) (5 hrs (Sessions Day 1))
    CL Item
    6 hrs (Sessions Day 1) (6 hrs (Sessions Day 1))
    CL Item
    8 hrs (Sessions Day 1) (8 hrs (Sessions Day 1))
    CL Item
    12 hrs (Sessions Day 1) (12 hrs (Sessions Day 1))
    CL Item
    24 hrs (Sessions Day 1) (24 hrs (Sessions Day 1))
    CL Item
    Early Withdrawal (Early Withdrawal)
    CL Item
    Follow-Up (Follow-Up)
    Actual Time
    Item
    Actual Time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Item
    Subject Position
    integer
    C0518766 (UMLS CUI [1,1])
    C1262869 (UMLS CUI [1,2])
    Subject Position
    Code List
    Subject Position
    CL Item
    standing (3)
    CL Item
    semi-supine (4)
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    Location of Temperature Measurement
    integer
    C0489453 (UMLS CUI [1])
    Location of Temperature Measurement
    Code List
    Location of Temperature Measurement
    CL Item
    oral (1)
    CL Item
    rectal (2)
    CL Item
    axilla (3)
    CL Item
    tympanic (4)
    CL Item
    intra-arterial (5)
    Respiration rate
    Item
    Respiration rate
    integer
    C0231832 (UMLS CUI [1])
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