0 Bedömningar

ID

30995

Beskrivning

This ODM file contains Dates of Laboratory Sample Taking (general, Haematology, Clinical Chemistry and Urinalysis). To be filled at Screening, Session 1 and 2 (Day -1 and Day 1, different extent and timepoints), 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.

Länk

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

Nyckelord

  1. 2018-06-08 2018-06-08 - Sarah Riepenhausen
  2. 2018-07-09 2018-07-09 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 juli 2018

DOI

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Licens

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

    Laboratory Data (All Part A Visits)

    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Type
    Beskrivning

    Form needs to be filled out on each attended visit mentioned below.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0545082
    Electronically transferred Laboratory Data
    Beskrivning

    Electronically transferred Laboratory Data

    Alias
    UMLS CUI-1
    C1705214
    Relative Time for Sessions 1 and 2
    Beskrivning

    Question only relevant for Session visits. Pre-dose and 2 hrs post-dose general Laboratory data, other relative times haematology, clinical chemistry and urinalysis. 72 hrs post-dose only necessary if 48 hrs post-dose assessments are abnormal.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0022885
    Type of Laboratory Data
    Beskrivning

    General/Unspecified: only to be chosen for Session 1/2 Day 1, pre-dose and 2 hrs post-dose. All other Session timepoints as well as all other visits need Clinical Chemistry, Haematology and Urinalysis.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0022885
    Date sample taken
    Beskrivning

    Date sample taken

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time sample taken
    Beskrivning

    Time sample taken

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345

    Similar models

    Laboratory Data (All Part A Visits)

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Code List
    Subject Identifier
    Item
    Visit Type
    text
    C0545082 (UMLS CUI [1])
    Code List
    Visit Type
    CL Item
    Screening (Screening)
    CL Item
    Session 1 (Session 1)
    CL Item
    Session 2 (Session 2)
    CL Item
    Follow-Up (Follow-Up)
    CL Item
    Early Withdrawal (Early Withdrawal)
    Item Group
    Electronically transferred Laboratory Data
    C1705214 (UMLS CUI-1)
    Item
    Relative Time for Sessions 1 and 2
    text
    C0439564 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0022885 (UMLS CUI [1,3])
    Code List
    Relative Time for Sessions 1 and 2
    CL Item
    Day -1 (Day -1)
    CL Item
    Day 1, Pre-dose (Day 1, Pre-dose)
    CL Item
    Day 1, 2 hrs post-dose (Day 1, 2 hrs post-dose)
    CL Item
    Day 1, 24 hrs post-dose (Day 1, 24 hrs post-dose)
    CL Item
    Day 1, 48 hrs post-dose (Day 1, 48 hrs post-dose)
    CL Item
    Day 1, 72 hrs post-dose (Day 1, 72 hrs post-dose)
    Item
    Type of Laboratory Data
    text
    C0022885 (UMLS CUI [1])
    Code List
    Type of Laboratory Data
    CL Item
    General/Unspecified (General/Unspecified)
    CL Item
    Haematology (Haematology)
    CL Item
    Clinical Chemistry (Clinical Chemistry)
    CL Item
    Urinalysis (Urinalysis)
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Time sample taken
    Item
    Actual Time sample taken
    text
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])

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