0 Ratings

ID

30548

Description

This ODM file contains Information about a Pregnancy Test and the last menstrual period. To be filled at Screening, Session 1 (Day -1), Session 2 (Day -1), Early Withdrawal and Follow-Up for female subjects only; LMP on Day -1 of Sessions. 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

  1. 6/13/18 6/13/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 13, 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

    Pregnancy Test and last menstrual Period

    Adminitrative Data
    Description

    Adminitrative Data

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

    Complete Form for each of the Visits in this Item, if attended by female subject.

    Data type

    integer

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

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Pregnancy Test
    Description

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    Date sample taken
    Description

    Date sample Taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    UMLS CUI [1,2]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    Results
    Description

    Results

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    Last Menstrual Period
    Description

    Last Menstrual Period

    Alias
    UMLS CUI-1
    C0025329 (Menstrual cycle)
    SNOMED
    78456001
    Date of last menstrual Period
    Description

    Not neccessary at Early Withdrawal and Follow up.

    Data type

    date

    Alias
    UMLS CUI [1]
    C0425932 (Date of last menstrual period)
    SNOMED
    21840007

    Similar models

    Pregnancy Test and last menstrual Period

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Adminitrative Data
    C1320722 (UMLS CUI-1)
    Item
    Type of Visit
    integer
    C0545082 (UMLS CUI [1])
    Code List
    Type of Visit
    CL Item
    Screening (1)
    CL Item
    Session 1 (Day -1) (2)
    CL Item
    Session 2 (Day -1) (3)
    CL Item
    Early Withdrawal (4)
    CL Item
    Follow-Up (5)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    Date sample Taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Item
    Results
    text
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Code List
    Results
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)
    Item Group
    Last Menstrual Period
    C0025329 (UMLS CUI-1)
    Date of Last menstrual period
    Item
    Date of last menstrual Period
    date
    C0425932 (UMLS CUI [1])

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