ID

34745

Beskrivning

Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders This form contains the conclusion of the study it should be filled out at the final visit.

Nyckelord

Versioner (2)
  1. 26/01/2019 26/01/2019 -
  2. 01/02/2019 01/02/2019 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 janvier 2019

DOI

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Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

    Engelsk

    Study Conclusion

    1 Formulär  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of subject completion or withdrawal
    Beskrivning

    Date of Completion or Withdrawal

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    UMLS CUI [2,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [2,2]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    Study Conclusion
    Beskrivning

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0008972 (Clinical Research)
    Was the subject withdrawn from the study?
    Beskrivning

    If Yes, tick the primary reason for withdrawal

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    If Yes, tick the primary reason for withdrawal:
    Beskrivning

    Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. If subject did not meet treatment eligibility criteria, ensure ’Clinically significant screening lab values’ and/or ’Clinically significant screening ECG abnormalities’ are ticked.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,3]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    Other, specify
    Beskrivning

    Other Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,2]
    C2348235 (Specification)
    UMLS CUI [2,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [2,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [2,3]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    Investigator Comment Log
    Beskrivning

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961 (Clinical Investigators)
    UMLS CUI-2
    C0947611 (Comment)
    LOINC
    LP72293-1
    CRF Page Number if Applicable
    Beskrivning

    CRF Page Number

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1704732 (Page (document))
    UMLS CUI [1,2]
    C1516308 (Case Report Form)
    Comment
    Beskrivning

    Only use this form to record explanatory information on anomalies such as missing data, sponsor waiver of inclusion/exclusion criteria, departures from planned investigational product administration or missed visits.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Signature
    Beskrivning

    Signature

    Alias
    UMLS CUI-1
    C1519316 (Signature)
    LOINC
    LP248948-4
    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.
    Beskrivning

    The Investigator is accountable for CRF data. However, the Principal Investigator may delegate CRF signature authority to a medically qualified Sub-investigator (as indicated on the Site Staff Signature Sheet).

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date
    Beskrivning

    Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Investigator's Name (print)
    Beskrivning

    Investigator's Name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
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    Similar models

    Study Conclusion

    1 Formulär
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Date of Completion or Withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C0422727 (UMLS CUI [2,2])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Item
    Was the subject withdrawn from the study?
    text
    C0422727 (UMLS CUI [1])
    Subject Withdrawal
    Code List
    Was the subject withdrawn from the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If Yes, tick the primary reason for withdrawal:
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Reason for Withdrawal
    Code List
    If Yes, tick the primary reason for withdrawal:
    CL Item
    Adverse event (Adverse event)
    CL Item
    Lost to follow-up (Lost to follow-up)
    CL Item
    Protocol violation (Protocol violation)
    CL Item
    Subject decided to withdraw from the study (Subject decided to withdraw from the study)
    CL Item
    Sponsor terminated study (Sponsor terminated study)
    CL Item
    Subject did not have opportunity to treat migraine (Subject did not have opportunity to treat migraine)
    CL Item
    Did not meet treatment eligibility criteria (Did not meet treatment eligibility criteria)
    CL Item
    Clinically significant screening lab values (Clinically significant screening lab values)
    CL Item
    Clinically significant screening ECG abnormalities (Clinically significant screening ECG abnormalities)
    CL Item
    Other (Other)
    Other Specification
    Item
    Other, specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [2,1])
    C0392360 (UMLS CUI [2,2])
    C0008976 (UMLS CUI [2,3])
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    CRF Page Number
    Item
    CRF Page Number if Applicable
    text
    C1704732 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Signature
    C1519316 (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])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Investigator's Name
    Item
    Investigator's Name (print)
    text
    C2826892 (UMLS CUI [1])
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