0 Beoordelingen
ID

30487

Beschrijving

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

Trefwoorden

Versies (1)
  1. 08-06-18 08-06-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

8 juni 2018

DOI

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Licentie

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

    Engels

    Vital Signs (All Visits)

    1 Formulieren  
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Visit Type
    Beschrijving

    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).

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0545082
    Subject Identifier
    Beschrijving

    Subject Identifier

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Beschrijving

    Date of Visit

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Vital Signs - Body Measures
    Beschrijving

    Vital Signs - Body Measures

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0203910
    Height
    Beschrijving

    Only mandatory at screening visit.

    Datatype

    integer

    Maateenheden
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Beschrijving

    Weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body Mass Index
    Beschrijving

    Only mandatory at screening visit.

    Datatype

    float

    Maateenheden
    • kg/m^2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m^2
    Hip Circumference
    Beschrijving

    Hip Circumference

    Datatype

    integer

    Maateenheden
    • cm
    Alias
    UMLS CUI [1]
    C0562350
    cm
    Waist Circumference
    Beschrijving

    Waist Circumference

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0455829
    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Beschrijving

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

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    Planned relative Time
    Beschrijving

    Planned relative Time

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439564
    Actual Time
    Beschrijving

    Actual Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Systolic Blood Pressure
    Beschrijving

    Systolic Blood Pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Beschrijving

    Diastolic Blood Pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Subject Position
    Beschrijving

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

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1262869
    Heart Rate
    Beschrijving

    Heart Rate

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Temperature
    Beschrijving

    Temperature

    Datatype

    float

    Maateenheden
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Location of Temperature Measurement
    Beschrijving

    Location of Temperature Measurement

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0489453
    Respiration rate
    Beschrijving

    Respiration rate

    Datatype

    integer

    Maateenheden
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832
    breaths/min
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    Similar models

    Vital Signs (All Visits)

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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