0 Ratings
ID

44429

Description

This ODM file contains Alcohol Breath Test, Cotinine Screen and Drug Screening. To be filled in at Screening and Sessions 1 and 2 (Day -1). 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

Versions (2)
  1. 08.06.18 08.06.18 - Sarah Riepenhausen
  2. 20.09.21 20.09.21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

20. September 2021

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

    English

    Alcohol Breath Test, Cotinine and Drugs Screenings (Screening and Sessions Visits)

    1 forms  
    Administrative Data
    Description

    Administrative Data

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

    Visit

    Data type

    text

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

    Subject Identifier

    Data type

    text

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

    Alcohol Breath Test

    Alias
    UMLS CUI-1
    C0202306 (Ethanol measurement, breath)
    SNOMED
    1820004
    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]
    C0202306 (Ethanol measurement, breath)
    SNOMED
    1820004
    Result
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202304 (Ethanol measurement)
    SNOMED
    430837008
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    Cotinine Screen
    Description

    Cotinine Screen

    Alias
    UMLS CUI-1
    C0202363 (Cotinine measurement)
    SNOMED
    33966007
    Date and Time sample Taken
    Description

    Date and Time sample Taken

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0202363 (Cotinine measurement)
    SNOMED
    33966007
    UMLS CUI [1,2]
    C1264639 (Date/Time)
    SNOMED
    118575009
    UMLS CUI [1,3]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    Cotinine Finding
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202363 (Cotinine measurement)
    SNOMED
    33966007
    UMLS CUI [1,2]
    C0243095 (Finding)
    LOINC
    LA9042-8
    Drug Screen
    Description

    Drug Screen

    Alias
    UMLS CUI-1
    C0373483 (Drug screen (procedure))
    Date and Time of Sample Taken
    Description

    Date and Time of Sample Taken

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0373483 (Drug screen (procedure))
    UMLS CUI [1,2]
    C1264639 (Date/Time)
    SNOMED
    118575009
    UMLS CUI [1,3]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    Drug
    Description

    Drug

    Data type

    text

    Alias
    UMLS CUI [1]
    C0086190 (Illicit Drugs)
    LOINC
    LP99406-8
    UMLS CUI [2]
    C0013146 (Drug abuse)
    SNOMED
    26416006
    LOINC
    LP36310-8
    Result
    Description

    If any of the drugs mentioned are positive, exclude subject from study

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040 (Result)
    SNOMED
    394617004
    UMLS CUI [1,2]
    C0373483 (Drug screen (procedure))
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    Similar models

    Alcohol Breath Test, Cotinine and Drugs Screenings (Screening and Sessions Visits)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Item
    Type of Visit
    text
    C0545082 (UMLS CUI [1])
    Visit
    Code List
    Type of Visit
    CL Item
    Screening (Screening)
    CL Item
    Session 1 (Day -1) (Session 1 (Day -1))
    CL Item
    Session 2 (Session 2)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Alcohol Breath Test
    C0202306 (UMLS CUI-1)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1,1])
    C0202306 (UMLS CUI [1,2])
    Item
    Result
    text
    C0202304 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result
    Code List
    Result
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item Group
    Cotinine Screen
    C0202363 (UMLS CUI-1)
    Date and Time sample Taken
    Item
    Date and Time sample Taken
    datetime
    C0202363 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    Item
    Cotinine Finding
    text
    C0202363 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Cotinine Finding
    Code List
    Cotinine Finding
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item Group
    Drug Screen
    C0373483 (UMLS CUI-1)
    Date and Time of Sample Taken
    Item
    Date and Time of Sample Taken
    datetime
    C0373483 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    Item
    Drug
    text
    C0086190 (UMLS CUI [1])
    C0013146 (UMLS CUI [2])
    Drug
    Code List
    Drug
    CL Item
    Cocaine (Cocaine)
    CL Item
    Aphetamines (Aphetamines)
    CL Item
    Benzodiazepines (Benzodiazepines)
    CL Item
    Cannabinoids (Cannabinoids)
    CL Item
    Opiates (Opiates)
    CL Item
    Barbiturates (Barbiturates)
    CL Item
    Methadone (Methadone)
    Item
    Result
    text
    C1274040 (UMLS CUI [1,1])
    C0373483 (UMLS CUI [1,2])
    Result
    Code List
    Result
    CL Item
    positive (positive)
    CL Item
    negative (negative)
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