0 Avaliações

ID

30995

Descrição

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.

Link

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

Palavras-chave

  1. 08/06/2018 08/06/2018 - Sarah Riepenhausen
  2. 09/07/2018 09/07/2018 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

9 de julho de 2018

DOI

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Licença

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
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Descrição

    Subject Identifier

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Type
    Descrição

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

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Electronically transferred Laboratory Data
    Descrição

    Electronically transferred Laboratory Data

    Alias
    UMLS CUI-1
    C1705214 (Laboratory Data Domain)
    Relative Time for Sessions 1 and 2
    Descrição

    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.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    UMLS CUI [1,3]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Type of Laboratory Data
    Descrição

    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.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Date sample taken
    Descrição

    Date sample taken

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Actual Time sample taken
    Descrição

    Time sample taken

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0200345 (Specimen Collection)
    SNOMED
    17636008

    Similar models

    Laboratory Data (All Part A Visits)

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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