0 Ratings
ID

30543

Description

This ODM file contains Holter and Telemetry Results. Holter part to be filled at Screening, Session 1 and 2 (Day -1 and Day 1), Telemetry part to be filled at Sessions 1 and 2 (Day 1 only). 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 (1)
  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

    English

    Holter (Screening, Session 1+2), Telemetry (Session 1 + 2)

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Type of Visit
    Description

    Visit

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082
    Holter
    Description

    Holter

    Alias
    UMLS CUI-1
    C0013801
    Planned relative Time on Day 1 of Sessions.
    Description

    Not to be filled at Screening or Day -1 of Sessions.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0013801
    Start Date of Holter
    Description

    Record the dates and times recorded by the Holter monitoring equipment.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C0808070
    Start Time of Holter
    Description

    Record the dates and times recorded by the Holter monitoring equipment.

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C1301880
    Stop Date of Holter
    Description

    Record the dates and times recorded by the Holter monitoring equipment.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C0806020
    Stop Time of Holter
    Description

    Record the dates and times recorded by the Holter monitoring equipment.

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C1522314
    Holter monitoring method
    Description

    Holter monitoring method

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C0871511
    Interpretation of Holter
    Description

    Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional Holter abnormalities page if clinically significant abnormalities are present.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C1274040
    Telemetry
    Description

    Telemetry

    Alias
    UMLS CUI-1
    C0039451
    Planned relative Time on Day 1 of Sessions
    Description

    Telemetry only mandatory on day 1 of Sessions. Not to be done at screening or Day -1 of Sessions.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0039451
    Start date of Telemetry
    Description

    Start date of Telemetry

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C0808070
    Start time of Telemetry
    Description

    Start time of Telemetry

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C1301880
    End date of Telemetry
    Description

    End date of Telemetry

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C0806020
    End time of Telemetry
    Description

    End time of Telemetry

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C1522314
    Result of Telemetry
    Description

    Result of Telemetry

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C1274040
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    Similar models

    Holter (Screening, Session 1+2), Telemetry (Session 1 + 2)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Type of Visit
    text
    C0545082 (UMLS CUI [1])
    Visit
    Code List
    Type of Visit
    CL Item
    Screening (Screening)
    (Comment:en)
    CL Item
    Session 1 (Day 1) (Session 1 (Day 1))
    (Comment:en)
    CL Item
    Session 2 (Day 1) (Session 2 (Day 1))
    (Comment:en)
    CL Item
    Unscheduled (Unscheduled)
    (Comment:en)
    CL Item
    Session 1 (Day -1) (Session 1 (Day -1))
    (Comment:en)
    CL Item
    Session 2 (Day -1) (Session 2 (Day -1))
    (Comment:en)
    Item Group
    Holter
    C0013801 (UMLS CUI-1)
    Item
    Planned relative Time on Day 1 of Sessions.
    text
    C0439564 (UMLS CUI [1,1])
    C0013801 (UMLS CUI [1,2])
    Planned relative Time
    Code List
    Planned relative Time on Day 1 of Sessions.
    CL Item
    Pre-Scan (Pre-Scan)
    CL Item
    Post-Scan (Post-Scan)
    Start Date of Holter
    Item
    Start Date of Holter
    date
    C0013801 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start Time of Holter
    Item
    Start Time of Holter
    time
    C0013801 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Stop Date of Holter
    Item
    Stop Date of Holter
    date
    C0013801 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Stop Time of Holter
    Item
    Stop Time of Holter
    time
    C0013801 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Holter monitoring method
    text
    C0013801 (UMLS CUI [1,1])
    C0871511 (UMLS CUI [1,2])
    Holter monitoring method
    Code List
    Holter monitoring method
    CL Item
    12 Lead 1000Hz (1)
    CL Item
    12 lead 180Hz (2)
    CL Item
    3 Lead 180 Hz (3)
    CL Item
    Telemetry (4)
    CL Item
    5 Lead 512Hz (5)
    CL Item
    4 Lead 0.05-40 Hz (6)
    CL Item
    6 Lead 0.05-40 Hz (7)
    CL Item
    7 Lead 0.05-100 Hz-3dB (8)
    CL Item
    7 Lead 3 channel 133 Hz (9)
    CL Item
    2 Lead 200 Hz (10)
    CL Item
    Other (OT)
    Item
    Interpretation of Holter
    integer
    C0013801 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result of ECG
    Code List
    Interpretation of Holter
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant (2)
    CL Item
    abnormal - clinically significant (3)
    CL Item
    no result (4)
    CL Item
    unable to evaluate (8)
    Item Group
    Telemetry
    C0039451 (UMLS CUI-1)
    Item
    Planned relative Time on Day 1 of Sessions
    text
    C0439564 (UMLS CUI [1,1])
    C0039451 (UMLS CUI [1,2])
    Planned relative Time
    Code List
    Planned relative Time on Day 1 of Sessions
    CL Item
    Pre-Scan (Pre-Scan)
    CL Item
    Post-Scan (Post-Scan)
    Start date of Telemetry
    Item
    Start date of Telemetry
    date
    C0039451 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start time of Telemetry
    Item
    Start time of Telemetry
    time
    C0039451 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    End date of Telemetry
    Item
    End date of Telemetry
    date
    C0039451 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    End time of Telemetry
    Item
    End time of Telemetry
    time
    C0039451 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Result of Telemetry
    integer
    C0039451 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result of ECG
    Code List
    Result of Telemetry
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant (2)
    CL Item
    abnormal - clinically significant (3)
    CL Item
    no result (4)
    CL Item
    unable to evaluate (8)
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