ID

30662

Descrição

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Palavras-chave

Versões (2)
  1. 2018-06-19 2018-06-19 -
  2. 2018-06-19 2018-06-19 -
Titular dos direitos

GlaxoSmithKline

Transferido a

19 juni 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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    TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024

    Inglês

    End of Study

    1 Formulários  
    1. StudyEvent: ODM
      1. End of Study
    Date of Visit/Assessment
    Descrição

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303
    Date of Visit/Assessment
    Descrição

    Date of Visit

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Status of Treatment Blind
    Descrição

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C0749659
    UMLS CUI-2
    C2347038
    Was the treatment blind broken during the study?
    Descrição

    treatment blind broken

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0749659
    UMLS CUI [1,2]
    C2347038
    If Yes, complete the date
    Descrição

    Was the treatment blind broken during the study?

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    If Yes, tick one reason below:
    Descrição

    Was the treatment blind broken during the study?

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Reason treatment blind broken. If other, specify:
    Descrição

    reason treatment blind broken

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Pregnancy information
    Descrição

    Pregnancy information

    Alias
    UMLS CUI-1
    C0032961
    Did the subject become pregnant during the study?
    Descrição

    If yes, please complete the Pregnancy Notification form.

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0032961
    Withdrawal of Consent for PGx (DNA)/Sample Destruction
    Descrição

    Withdrawal of Consent for PGx (DNA)/Sample Destruction

    Alias
    UMLS CUI-1
    C1707492
    UMLS CUI-2
    C1948029
    UMLS CUI-3
    C0178913
    Has subject withdrawn consent for PGx research?
    Descrição

    withdrawn consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1707492
    Yes, date informed consent withdrawn
    Descrição

    Date informed consent withdrawn

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C0011008
    Ha a request been made for sample destruction?
    Descrição

    Sample destruction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    Yes, check reason for sample destruction
    Descrição

    Reason for sample destruction

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0392360
    If Other Reason for sample destruction, specify
    Descrição

    Reason for sample destruction

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0392360
    Study conclusion
    Descrição

    Study conclusion

    1. Date of subject completion or withdrawal
    Descrição

    Date of subject completion or withdrawal

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2983670
    2. Was the subject withdrawn from the study before study reached GSK target number of primary clinical endpoints?
    Descrição

    subject withdrawal

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0422727
    3. Primary reason for withdrawal
    Descrição

    Primary reason for withdrawal

    Tipo de dados

    integer

    If subject withdrew consent, provide comment
    Descrição

    Pre-defined sub-reasons are optional. The following primary reasons are optional : 2, 4 and 7. Pre-defined sub-reasons may/should be moved under appropriate primary reasons. See specific note for Group DSRS8.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1707492
    If investigator site closed, provide comment
    Descrição

    Pre-defined sub-reasons are optional. The following primary reasons are optional : 2, 4 and 7. Pre-defined sub-reasons may/should be moved under appropriate primary reasons. See specific note for Group DSRS8.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1710101
    If subject reached stopping criteria: Subject did not have opportunity to treat migraine?
    Descrição

    no opportunity to treat migraine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0332155
    5. Q1
    Descrição

    [hidden] Item is not required

    Tipo de dados

    boolean

    6. Q2
    Descrição

    [hidden] Item is not required

    Tipo de dados

    text

    Investigators signature
    Descrição

    Investigators signature

    Alias
    UMLS CUI-1
    C2346576
    For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
    Descrição

    By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances. [hidden]. Item is not required.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1706256
    Is this casebook ready to sign? Investigator Signature
    Descrição

    Investigator Signature

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2346576
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    Similar models

    End of Study

    1 Formulários
    1. StudyEvent: ODM
      1. End of Study
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Date of Visit/Assessment
    C1320303 (UMLS CUI-1)
    Date of Visit
    Item
    Date of Visit/Assessment
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    treatment blind broken
    Item
    Was the treatment blind broken during the study?
    boolean
    C0749659 (UMLS CUI [1,1])
    C2347038 (UMLS CUI [1,2])
    date treatment blind broken
    Item
    If Yes, complete the date
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    If Yes, tick one reason below:
    integer
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    reason treatment blind broken
    Code List
    If Yes, tick one reason below:
    CL Item
    Medical emergency requiring identification of investigational product for further treatments (1)
    CL Item
    Other (2)
    reason treatment blind broken
    Item
    Reason treatment blind broken. If other, specify:
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Item Group
    Pregnancy information
    C0032961 (UMLS CUI-1)
    Item
    Did the subject become pregnant during the study?
    integer
    C0032961 (UMLS CUI [1])
    Pregnancy
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Withdrawal of Consent for PGx (DNA)/Sample Destruction
    C1707492 (UMLS CUI-1)
    C1948029 (UMLS CUI-2)
    C0178913 (UMLS CUI-3)
    withdrawn consent
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C1707492 (UMLS CUI [1])
    Date informed consent withdrawn
    Item
    Yes, date informed consent withdrawn
    date
    C1707492 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Sample destruction
    Item
    Ha a request been made for sample destruction?
    boolean
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    Item
    Yes, check reason for sample destruction
    integer
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Reason for sample destruction
    Code List
    Yes, check reason for sample destruction
    CL Item
    Subject withdrew consent for PGx (1)
    CL Item
    Screen failure (2)
    CL Item
    Other, specify (3)
    Reason for sample destruction
    Item
    If Other Reason for sample destruction, specify
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Item Group
    Study conclusion
    Date of subject completion or withdrawal
    Item
    1. Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    Item
    2. Was the subject withdrawn from the study before study reached GSK target number of primary clinical endpoints?
    text
    C0422727 (UMLS CUI [1])
    subject withdrawal
    Code List
    2. Was the subject withdrawn from the study before study reached GSK target number of primary clinical endpoints?
    CL Item
    No (N)
    CL Item
    Yes, complete primary reason for withdrawal (Y)
    Item
    3. Primary reason for withdrawal
    integer
    Primary reason for withdrawal
    Code List
    3. Primary reason for withdrawal
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to follow-up (6)
    CL Item
    Withdrew consent, specify! (8)
    CL Item
    Adverse Event (1)
    CL Item
    Subject reached protocol defined stopping criteria (2)
    CL Item
    Lack of efficacy (3)
    CL Item
    Protocol deviation (4)
    CL Item
    Investigator discretion, specify! (7)
    withdrawal of consent comment
    Item
    If subject withdrew consent, provide comment
    text
    C0947611 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    investigator site closed comment
    Item
    If investigator site closed, provide comment
    text
    C0947611 (UMLS CUI [1,1])
    C1710101 (UMLS CUI [1,2])
    no opportunity to treat migraine
    Item
    If subject reached stopping criteria: Subject did not have opportunity to treat migraine?
    boolean
    C0149931 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    Q1
    Item
    5. Q1
    boolean
    Item
    6. Q2
    text
    Q2
    Code List
    6. Q2
    CL Item
    PF_SC_LOST (PF_SC_LOST)
    CL Item
    [?] PF_SC_DEATH ([?] PF_SC_DEATH)
    CL Item
    [?] PF_SC_SPONSORDECISION ([?] PF_SC_SPONSORDECISION)
    CL Item
    PF_SC_PHYSICIANDECISION (PF_SC_PHYSICIANDECISION)
    CL Item
    PF_SC_PATIENTDECISION (PF_SC_PATIENTDECISION)
    CL Item
    PF_SC_AE (PF_SC_AE)
    CL Item
    PF_SC_ALE (PF_SC_ALE)
    CL Item
    PF_SC_CRITERIA (PF_SC_CRITERIA)
    CL Item
    PF_SC_OTHER (PF_SC_OTHER)
    Item Group
    Investigators signature
    C2346576 (UMLS CUI-1)
    re-sign case book
    Item
    For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
    boolean
    C1706256 (UMLS CUI [1])
    Investigator Signature
    Item
    Is this casebook ready to sign? Investigator Signature
    boolean
    C2346576 (UMLS CUI [1])
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