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ID

30489

Description

This ODM file contains Physical Examination documentation. To be filled in at Screening, Early Withdrawal and Follow-Up Visits. 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.

Lien

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

Mots-clés

  1. 08/06/2018 08/06/2018 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

8 juin 2018

DOI

Pour une demande vous connecter.

Licence

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

    Physical Examination (Screening, Early Withdrawal, Follow-Up)

    Administrative Data
    Description

    Administrative Data

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

    Visit

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Date of Visit
    Description

    Date of Visit

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Subject Identifier
    Description

    Subject Identifier

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Physical examination
    Description

    Physical examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Organ System examined
    Description

    Examine all mentioned systems. Breast may be left out.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0460002 (body system)
    SNOMED
    91689009
    UMLS CUI [1,2]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Finding in Examination
    Description

    Not Done only possible for the examination of Breasts.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0243095 (Finding)
    LOINC
    LA9042-8
    If abnormal, describe concisely
    Description

    different findings should be separated by either a (;) or a (/)

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2826279 (Abnormal Finding)
    UMLS CUI [1,2]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014

    Similar models

    Physical Examination (Screening, Early Withdrawal, Follow-Up)

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Item
    Type of Visit
    text
    C0545082 (UMLS CUI [1])
    Code List
    Type of Visit
    CL Item
    Screening (Screening)
    CL Item
    Early Withdrawal (Early Withdrawal)
    CL Item
    Follow-Up (Follow-Up)
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Physical examination
    C0031809 (UMLS CUI-1)
    Item
    Organ System examined
    integer
    C0460002 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    Code List
    Organ System examined
    CL Item
    Hair and Skin (1)
    CL Item
    Lymph Nodes (2)
    CL Item
    Eyes (3)
    CL Item
    Ears, Nose and Throat (4)
    CL Item
    Breasts (5)
    CL Item
    Respiratory (6)
    CL Item
    Cardiovascular (7)
    CL Item
    Abdomen (8)
    CL Item
    Musculoskeletal (9)
    CL Item
    Neurological (10)
    CL Item
    Thyroid (11)
    Item
    Finding in Examination
    text
    C0031809 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Code List
    Finding in Examination
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not done (Not done)
    Abnormal Finding
    Item
    If abnormal, describe concisely
    text
    C2826279 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])

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