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ID

30859

Description

This ODM file contains Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log and Signature. To be filled if study concluded or withdrawal from study for any reason. 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. 27/06/18 27/06/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

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27 giugno 2018

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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

    Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log

    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
    Liver Events Assessment
    Description

    Liver Events Assessment

    Alias
    UMLS CUI-1
    C0232741
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0220825
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    Description

    To be checked on Session Days 1 pre-dose, 2 hours post-dose and 72 hours post-dose. If Yes, - Stop investigational product and complete date stopped on Investigational Product form. - Contact GSK within 24 hours of occurrence of liver event by phone or fax. - If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. - Obtain tests as per protocol. - Obtain Blood sample for pharmacokinetic (PK) analysis within 24 hours of last dose. - Complete Liver Events Forms.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C0220825
    Status of Treatment Blind
    Description

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C3897431
    Was the treatment blind broken during the study?
    Description

    Treatment Blind Broken

    Data type

    text

    Alias
    UMLS CUI [1]
    C3897431
    If yes, date blind broken
    Description

    This is the date the Investigator is made aware of the blind being broken. Record either: Date blind was broken by Investigator or Date Investigator notified by GSK that the blind has been/was broken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    If yes, time blind broken
    Description

    Time blind broken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0040223
    Reason blind broken, pick one
    Description

    Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Other Reason blind broken, specify
    Description

    Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0205394
    Pregnancy Information
    Description

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant during the study?
    Description

    If Yes, complete Pregnancy Notification form. Not Applicable: not of childbearing potential or male

    Data type

    text

    Alias
    UMLS CUI [1]
    C3828490
    Did a female partner of the male subject become pregnant during the study?
    Description

    If Yes, complete Pregnancy Notification form. Not Applicable: subject is female, female partner not of childbearing potential or no female partner)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3828490
    UMLS CUI [1,2]
    C0919624
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    Date of last contact
    Description

    Refer to protocol section(s) to evaluate subject completion or withdrawal from the study. If the subject completed the study: ’Date of last contact’ must match the last actual contact with the subject whether or not the contact was a clinic visit. If the subject withdrew from the study: ’Date of decision to withdraw’ must match the date of subject withdrawal. ’Date of last contact’ must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note:An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

    Data type

    date

    Alias
    UMLS CUI [1]
    C0805839
    Was the subject withdrawn from the study?
    Description

    Withdrawal from study

    Data type

    text

    Alias
    UMLS CUI [1]
    C0422727
    If Yes, pick one primary reason for withdrawal:
    Description

    If Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. Withdrew consent: Only pick, if none of the other primary reasons are appropriate

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    Specify reason for withdrawal
    Description

    Reason for withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0947611
    Date of decision to withdraw
    Description

    Date of decision to withdraw

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0679006
    UMLS CUI [1,3]
    C0011008
    Investigator Comment Log
    Description

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C0947611
    CRF patge number if applicable
    Description

    CRF page number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C1516308
    Comment
    Description

    Only use this to record explanatory information on anomalies such as missing data, departures from planned investigational product administration or missed visits.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Investigator's signature
    Description

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
    Description

    Investigator's signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's name (print)
    Description

    Investigator's name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Signature date
    Description

    Signature Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log

    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 Group
    Liver Events Assessment
    C0232741 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    Item
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    text
    C0232741 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [1,3])
    Liver Events Assessment
    Code List
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Status of Treatment Blind
    C3897431 (UMLS CUI-1)
    Item
    Was the treatment blind broken during the study?
    text
    C3897431 (UMLS CUI [1])
    Treatment Blind Broken
    Code List
    Was the treatment blind broken during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date blind broken
    Item
    If yes, date blind broken
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time blind broken
    Item
    If yes, time blind broken
    time
    C3897431 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Reason blind broken, pick one
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason blind broken
    Code List
    Reason blind broken, pick one
    CL Item
    Medical emergency requiring identification of investigational product for further treatment (1)
    CL Item
    Other (Z)
    Other Reason blind broken
    Item
    Other Reason blind broken, specify
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did the subject become pregnant during the study?
    text
    C3828490 (UMLS CUI [1])
    Subject pregnant during study
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not Applicable (X)
    Item
    Did a female partner of the male subject become pregnant during the study?
    text
    C3828490 (UMLS CUI [1,1])
    C0919624 (UMLS CUI [1,2])
    Subject pregnant during study
    Code List
    Did a female partner of the male subject become pregnant during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not Applicable (X)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Date of last contact
    Item
    Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Item
    Was the subject withdrawn from the study?
    text
    C0422727 (UMLS CUI [1])
    Liver Events Assessment
    Code List
    Was the subject withdrawn from the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If Yes, pick one primary reason for withdrawal:
    integer
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Primary Reason for withdrawal
    Code List
    If Yes, pick one primary reason for withdrawal:
    CL Item
    Adverse Event (1)
    CL Item
    Protocol deviation (3)
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to follow-up (6)
    CL Item
    Withdrew consent (8)
    Reason for withdrawal
    Item
    Specify reason for withdrawal
    text
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Date of decision to withdraw
    Item
    Date of decision to withdraw
    date
    C0422727 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    CRF page number
    Item
    CRF patge number if applicable
    integer
    C1704732 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
    text
    C2346576 (UMLS CUI [1])
    Investigator's name
    Item
    Investigator's name (print)
    text
    C2826892 (UMLS CUI [1])
    Signature Date
    Item
    Signature date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Back to the top of the page 

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