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ID

38563

Description

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Keywords

Versions (2)
  1. 10/24/19 10/24/19 -
  2. 10/24/19 10/24/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 24, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636

    English

    End of Study

    1 forms  
    1. StudyEvent: ODM
      1. End of Study
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Site
    Description

    Study Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164
    Patient
    Description

    Patient name

    Data type

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient No
    Description

    Patients, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1300638
    Date of Visit/Assessment
    Description

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303
    UMLS CUI-2
    C2985720
    Date of visit/assessment
    Description

    Date of visit; Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    Pharmacogenetic (PGx) Research Withdrawal of Consent
    Description

    Pharmacogenetic (PGx) Research Withdrawal of Consent

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    UMLS CUI-3
    C2349954
    Has subject withdrawn consent for PGx research?
    Description

    Pharmacogenetic Test, Informed Consent, Withdraw

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2349954
    Yes, date informed consent withdrawn
    Description

    Pharmacogenetic Test, Informed Consent, Withdraw, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2349954
    UMLS CUI [1,4]
    C0011008
    Has a request been made for blood sample destruction?
    Description

    Pharmacogenetic Test, Blood specimen, Destruction, Request

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1948029
    UMLS CUI [1,4]
    C1272683
    Yes, check reason
    Description

    Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1948029
    UMLS CUI [1,4]
    C1272683
    UMLS CUI [1,5]
    C0566251
    Other, specify
    Description

    Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1948029
    UMLS CUI [1,4]
    C1272683
    UMLS CUI [1,5]
    C0566251
    Status of Treatment Blind
    Description

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C2347038
    UMLS CUI-2
    C0449438
    Was the treatment blind broken during the study?
    Description

    Blinded Clinical Study, Subject Unblinding Event Record

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347038
    UMLS CUI [1,2]
    C3897431
    Yes, Date blind broken
    Description

    Blinded Clinical Study, Subject Unblinding Event Record, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347038
    UMLS CUI [1,2]
    C3897431
    UMLS CUI [1,3]
    C0011008
    Yes, Reason blind broken
    Description

    Blinded Clinical Study, Subject Unblinding Event Record, Reason and justification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347038
    UMLS CUI [1,2]
    C3897431
    UMLS CUI [1,3]
    C0566251
    Other, specify
    Description

    Blinded Clinical Study, Subject Unblinding Event Record, Reason and justification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347038
    UMLS CUI [1,2]
    C3897431
    UMLS CUI [1,3]
    C0566251
    Medical Device Question
    Description

    Medical Device Question

    Alias
    UMLS CUI-1
    C0025080
    UMLS CUI-2
    C1522634
    Did the subject experience an incident or near incident with GSK medical devices provided for use during this study?
    Description

    Medical Devices, Incident

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0025080
    UMLS CUI [1,2]
    C1551358
    Pregnancy Information
    Description

    Pregnancy Information

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

    Pregnancy, During, Clinical Trials

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008976
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C1707478
    Date of subject completion or withdrawal
    Description

    Completion Status, Date in time; Withdraw, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0805732
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2,1]
    C2349954
    UMLS CUI [2,2]
    C0011008
    Was the subject withdrawn from the study?
    Description

    Patient withdrawn from trial

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Yes, Primary reason for withdrawal
    Description

    Patient withdrawn from trial, Reason and justification, Primary

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205225
    Specify
    Description

    Patient withdrawn from trial, Reason and justification, Primary

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205225
    For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
    Description

    Clinical study case, Investigator Signature

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706256
    UMLS CUI [1,2]
    C2346576
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    Similar models

    End of Study

    1 forms
    1. StudyEvent: ODM
      1. End of Study
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Study Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Patient name
    Item
    Patient
    text
    C1299487 (UMLS CUI [1])
    Patients, Identification number
    Item
    Patient No
    integer
    C0030705 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Item Group
    Date of Visit/Assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of visit; Assessment Date
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    C2985720 (UMLS CUI [2])
    Item Group
    Pharmacogenetic (PGx) Research Withdrawal of Consent
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    C2349954 (UMLS CUI-3)
    Pharmacogenetic Test, Informed Consent, Withdraw
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
    Item
    Yes, date informed consent withdrawn
    date
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Pharmacogenetic Test, Blood specimen, Destruction, Request
    Item
    Has a request been made for blood sample destruction?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1948029 (UMLS CUI [1,3])
    C1272683 (UMLS CUI [1,4])
    Item
    Yes, check reason
    text
    C2347500 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1948029 (UMLS CUI [1,3])
    C1272683 (UMLS CUI [1,4])
    C0566251 (UMLS CUI [1,5])
    Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
    Code List
    Yes, check reason
    CL Item
    Subject withdrew consent for PGx  (1)
    CL Item
    Screen failure (2)
    CL Item
    Other, specify (3)
    Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
    Item
    Other, specify
    text
    C2347500 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1948029 (UMLS CUI [1,3])
    C1272683 (UMLS CUI [1,4])
    C0566251 (UMLS CUI [1,5])
    Item Group
    Status of Treatment Blind
    C2347038 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Blinded Clinical Study, Subject Unblinding Event Record
    Item
    Was the treatment blind broken during the study?
    boolean
    C2347038 (UMLS CUI [1,1])
    C3897431 (UMLS CUI [1,2])
    Blinded Clinical Study, Subject Unblinding Event Record, Date in time
    Item
    Yes, Date blind broken
    date
    C2347038 (UMLS CUI [1,1])
    C3897431 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Yes, Reason blind broken
    text
    C2347038 (UMLS CUI [1,1])
    C3897431 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Blinded Clinical Study, Subject Unblinding Event Record, Reason and justification
    Code List
    Yes, Reason blind broken
    CL Item
    Medical emergency requiring identification of investigational product for further treatment (1)
    CL Item
    Other, specify (2)
    Blinded Clinical Study, Subject Unblinding Event Record, Reason and justification
    Item
    Other, specify
    text
    C2347038 (UMLS CUI [1,1])
    C3897431 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Item Group
    Medical Device Question
    C0025080 (UMLS CUI-1)
    C1522634 (UMLS CUI-2)
    Medical Devices, Incident
    Item
    Did the subject experience an incident or near incident with GSK medical devices provided for use during this study?
    boolean
    C0025080 (UMLS CUI [1,1])
    C1551358 (UMLS CUI [1,2])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Pregnancy, During, Clinical Trials
    Item
    Did the subject become pregnant during the study?
    boolean
    C0032961 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Item Group
    Study Conclusion
    C0008976 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Completion Status, Date in time; Withdraw, Date in time
    Item
    Date of subject completion or withdrawal
    date
    C0805732 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    Patient withdrawn from trial
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    Yes, Primary reason for withdrawal
    text
    C0422727 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205225 (UMLS CUI [1,3])
    Patient withdrawn from trial, Reason and justification, Primary
    Code List
    Yes, Primary reason for withdrawal
    CL Item
    Adverse Event - No subreasons (1)
    CL Item
    Adverse Event - Subject met the GSK defined Liver Chemistry Stopping Criteria (2)
    CL Item
    Lack of efficacy  (3)
    CL Item
    Protocol deviation - No subreasons (4)
    CL Item
    Protocol deviation - Subject failed to provide T-SMBP measurements for 2 migraine attacks per month  (5)
    CL Item
    Protocol deviation - Prohibited medication use (6)
    CL Item
    Protocol deviation - New information about subject's history violates inclusion/exclusion criteria (7)
    CL Item
    Protocol deviation - New information about subject's meds violates inclusion/exclusion criteria  (8)
    CL Item
    Protocol deviation - Glycosylated hemoglobin >=8.0 (9)
    CL Item
    Subject reached protocol defined stopping criteria - No subreasons (9)
    CL Item
    Subject reached protocol defined stopping criteria - Monthly avg BP >= 140/90 mmHg on T-SMBP confirmed by rpt measurement in clinic (10)
    CL Item
    Subject reached protocol defined stopping criteria - Monthly avg incr >= 30 mmHg Sys or >= 20 mmHg Dia from in-clinic screening BP on T-SMBP confirmed in clinic (11)
    CL Item
    Subject reached protocol defined stopping criteria - Sys BP >=140 mmHg or Dia BP >= 90 mm Hg on consecutive visits at least 2wks apart (12)
    CL Item
    Subject reached protocol defined stopping criteria - Pregnancy (13)
    CL Item
    Subject reached protocol defined stopping criteria - Insufficient attacks(After first 3 months of treatment period, subject has treated on average <2 migraine attacks/month)  (14)
    CL Item
    Study closed/terminated (15)
    CL Item
    Lost to follow-up (15)
    CL Item
    Investigator discretion, specify  (16)
    CL Item
    Withdrew consent, Specify (17)
    Patient withdrawn from trial, Reason and justification, Primary
    Item
    Specify
    text
    C0422727 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205225 (UMLS CUI [1,3])
    Clinical study case, Investigator Signature
    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 [1,1])
    C2346576 (UMLS CUI [1,2])
    Back to the top of the page 

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