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ID

34505

Descrição

https://www.gsk-clinicalstudyregister.com/study/101998#rs 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 Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form asks for the inclusion and exclusion criteria of the study and should be filled out at the screening visit.

Link

https://www.gsk-clinicalstudyregister.com/study/101998#rs

Palavras-chave

Versões (6)
  1. 20/06/2018 20/06/2018 - Halim Ugurlu
  2. 11/01/2019 11/01/2019 -
  3. 13/01/2019 13/01/2019 -
  4. 18/01/2019 18/01/2019 -
  5. 18/01/2019 18/01/2019 - Sarah Riepenhausen
  6. 20/09/2021 20/09/2021 -
Titular dos direitos

GlaxoSmithKline (GSK)

Transferido a

18 de janeiro de 2019

DOI

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Licença

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

    Inglês

    Eligibility Criteria

    1 Formulários  
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Administrative Information
    Descrição

    Administrative Information

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descrição

    Subject Identifier

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Descrição

    Centre Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Visit Date
    Descrição

    Visit Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Eligibility Question
    Descrição

    Eligibility Question

    Alias
    UMLS CUI-1
    C0013893
    Did the subject meet all the entry criteria?
    Descrição

    If No, select all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1516637
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    UMLS CUI-2
    C1516637
    Subject is at least 18 years, but not more than 65 years of age at the screening visit.
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Subject is male or female
    Descrição

    A female is eligible to enter and participate in this study if she is of: a) non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b) child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and agrees to one of the following: •Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval (5 days) after completion or premature discontinuation from the study to account for elimination of the investigational drug; subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent when they present to the clinic for the Final Visit or, •Female sterilization; or, •Sterilization of male partner; or, •Implants of levonorgestrel; or, •Injectable progestogen; or, •Oral contraceptive (combined or progestogen only); or, •Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or, •Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm) •Any other Barrier method (only if used in combination with any of the above acceptable methods) or, •Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0150831
    Subject has at least a 6 month history that meets 2004 IHS Criteria for migraine with aura (ICHD-II 1.2.1) or migraine without aura (ICHD-II 1.1)
    Descrição

    At least a 6 month history of migraine with aura or migraine without aura

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0154723
    UMLS CUI [2]
    C1389175
    Subject has experienced 2-6 migraine attacks per month in the three months prior to screening
    Descrição

    2-6 migraine attacks per month in the three months prior to screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C1304680
    UMLS CUI [1,3]
    C0439507
    Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
    Descrição

    Moderate to Severe Migraine Pain

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2957106
    UMLS CUI [1,2]
    C0149931
    UMLS CUI [2,1]
    C0018681
    UMLS CUI [2,2]
    C0205081
    UMLS CUI [2,3]
    C0149931
    Subject is able to distinguish between mild migraine pain and other headache types
    Descrição

    Able to distinguish between mild migraine pain and other headache types

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340
    UMLS CUI [1,2]
    C0278138
    UMLS CUI [1,3]
    C0149931
    UMLS CUI [1,4]
    C0018681
    UMLS CUI [1,5]
    C0205394
    Subject is able to read, comprehend and complete subject diaries and understand that they must treat their migraine during the mild pain phase.
    Descrição

    Able to read, comprehend and complete subject diaries

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0586740
    UMLS CUI [2]
    C0162340
    UMLS CUI [3]
    C0584993
    UMLS CUI [4]
    C1321605
    Subject is able and willing to give written informed consent to participate in the study.
    Descrição

    Able and willing to give written informed consent to participate in the study

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal ’ s angina/coronary vasospasm, or signs/symptoms consistent with any of the above.
    Descrição

    ischemic heart disease, Prinzmetal ’ s angina/coronary vasospasm, or signs/symptoms consistent with any of the above

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0010068
    UMLS CUI [2]
    C0151744
    UMLS CUI [3]
    C0085616
    UMLS CUI [4]
    C0002963
    Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud ’ s Syndrome
    Descrição

    Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud ’ s Syndrome

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0034734
    UMLS CUI [2]
    C1881056
    UMLS CUI [3]
    C0853812
    Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator ’ s opinion, contraindicates participation in this study.
    Descrição

    cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1832603
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [2,1]
    C0003811
    UMLS CUI [2,2]
    C0332121
    Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).
    Descrição

    history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    UMLS CUI [2]
    C0007787
    Subject has a history of congenital heart disease.
    Descrição

    history of congenital heart disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0152021
    UMLS CUI [1,2]
    C0262926
    Subject has uncontrolled hypertension at screening (sitting systolic pressure > 160mmHg, diastolic pressure > 95mmHg).
    Descrição

    uncontrolled hypertension

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1868885
    Subject, in the investigator ’ s opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (including but is not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age)
    Descrição

    unrecognized cardiovascular or cerebrovascular disease, e.g. Hypertension, Hypercholestrinemia, smoker, obesity, diabetes, family history of CAD, female in menopause, male over 40

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C4288068
    UMLS CUI [2,1]
    C0007820
    UMLS CUI [2,2]
    C4288068
    UMLS CUI [3]
    C0020538
    UMLS CUI [4]
    C0020443
    UMLS CUI [5]
    C0543414
    UMLS CUI [6]
    C0028754
    UMLS CUI [7]
    C0011849
    UMLS CUI [8]
    C2317524
    UMLS CUI [9,1]
    C0086287
    UMLS CUI [9,2]
    C0025320
    UMLS CUI [10,1]
    C0086582
    UMLS CUI [10,2]
    C0001779
    Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening
    Descrição

    history of epilepsy or structural brain lesions

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0014544
    UMLS CUI [2]
    C0851391
    Subject has basilar (ICHD-II 1.2.6) or hemiplegic (ICHD-II 1.2.4) migraine.
    Descrição

    Subject has basilar (ICHD-II 1.2.6) or hemiplegic (ICHD-II 1.2.4) migraine.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0270860
    UMLS CUI [2]
    C0270862
    Subject has a history of impaired hepatic or renal function that, in the investigator ’ s opinion, contraindicates participation in this study
    Descrição

    impaired hepatic or renal function

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0086565
    UMLS CUI [2]
    C1565489
    Subject has had headache > 15 days/month in either of the three months prior to screening
    Descrição

    Subject has had headache > 15 days/month in either of the three months prior to screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0018681
    UMLS CUI [1,2]
    C0556971
    Subject has < 15 days/month of headache-free days in either of the three months prior to screening
    Descrição

    Subject has < 15 days/month of headache-free days in either of the three months prior to screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3843208
    UMLS CUI [1,2]
    C0556971
    Subject is currently taking a monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment
    Descrição

    monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0026457
    Subject is currently taking or has taken in the previous three months, a migraine prophylactic medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide
    Descrição

    migraine prophylactic medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0420172
    UMLS CUI [2]
    C0025842
    UMLS CUI [3]
    C0012291
    UMLS CUI [4]
    C0014710
    Subject is currently taking any anti-coagulant (e.g., Coumadin).
    Descrição

    Subject is currently taking any anti-coagulant (e.g., Coumadin).

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0699129
    UMLS CUI [2]
    C0003280
    Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John ’ s Wort (Hypericum perforatum)
    Descrição

    herbal preparations containing St. John ’ s Wort

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0936242
    UMLS CUI [1,2]
    C0332256
    UMLS CUI [1,3]
    C1360419
    Subject has hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of its components or any other 5-HT 1 receptor agonist.
    Descrição

    hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0337443
    UMLS CUI [1,2]
    C0020517
    UMLS CUI [1,3]
    C1301624
    UMLS CUI [1,4]
    C0075632
    UMLS CUI [1,5]
    C0027396
    Subject has a history of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, and nasal polyps.
    Descrição

    History of Allergic Reactions to Naproxen or NSAID induced Asthma, Rhinits and Nasal Polyps

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2106654
    UMLS CUI [2,1]
    C2106654
    UMLS CUI [2,2]
    C0004057
    UMLS CUI [3,1]
    C2106654
    UMLS CUI [3,2]
    C0027396
    UMLS CUI [4,1]
    C2106654
    UMLS CUI [4,2]
    C0003211
    UMLS CUI [5]
    C0004096
    UMLS CUI [6]
    C0035455
    UMLS CUI [7]
    C0027430
    Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
    Descrição

    History of Gastrointestinal Surgery that Indicates History of Bleeding, Ulceration or Perforation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0524722
    UMLS CUI [2]
    C1963975
    UMLS CUI [3]
    C0017181
    UMLS CUI [4]
    C0151664
    UMLS CUI [5]
    C0262926
    Subject has a history of gastric bypass or stapling surgery
    Descrição

    Subject has a history of gastric bypass or stapling surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0017125
    UMLS CUI [2]
    C0543467
    Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
    Descrição

    GI ulceration in the past six months or gastrointestinal bleeding in the past year

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0237938
    UMLS CUI [1,2]
    C4086728
    UMLS CUI [2,1]
    C0017181
    UMLS CUI [2,2]
    C3828652
    Subject has a history of inflammatory bowel disease
    Descrição

    Subject has a history of inflammatory bowel disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021390
    Subject has a history of any bleeding disorder
    Descrição

    Subject has a history of any bleeding disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005779
    Subject is taking any antiplatelet agent (except low-dose aspirin < 325 mg/day for cardioprotective reasons).
    Descrição

    antiplatelet agent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1096021
    UMLS CUI [1,2]
    C0332300
    UMLS CUI [1,3]
    C0004057
    UMLS CUI [1,4]
    C0445550
    Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
    Descrição

    Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0003015
    UMLS CUI [2]
    C0521942
    Subject is pregnant, actively trying to become pregnant or breast-feeding
    Descrição

    Subject is pregnant, actively trying to become pregnant or breast-feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    Subject has evidence of alcohol or substance abuse within the last year which, in the investigator's judgement, will likely interfere with the study conduct, subject co-operation, or evaluation and interpretation of the study results
    Descrição

    alcohol or substance abuse

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0085762
    UMLS CUI [2]
    C0038586
    Subject has any concurrent medical or psychiatric condition which, in the investigator's opinion, may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in this clinical trial.
    Descrição

    concurrent medical or psychiatric condition

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [2]
    C0004936
    Subject has participated in an investigational drug trial within the previous four weeks (excepting a previous study evaluating Trexima in which case an interval of at least 7 days have elapsed since discharge from previous Trexima trial), or plans to participate in another study at any time during this study
    Descrição

    Investigational drug trial within the previous four weeks

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0013230
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    Eligibility Criteria

    1 Formulários
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative Information
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Eligibility Question
    C0013893 (UMLS CUI-1)
    Did the subject meet all the entry criteria?
    Item
    Did the subject meet all the entry criteria?
    boolean
    C1516637 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    C1516637 (UMLS CUI-2)
    Age
    Item
    Subject is at least 18 years, but not more than 65 years of age at the screening visit.
    boolean
    C0001779 (UMLS CUI [1])
    Sex
    Item
    Subject is male or female
    text
    C0150831 (UMLS CUI [1])
    At least a 6 month history of migraine with aura or migraine without aura
    Item
    Subject has at least a 6 month history that meets 2004 IHS Criteria for migraine with aura (ICHD-II 1.2.1) or migraine without aura (ICHD-II 1.1)
    boolean
    C0154723 (UMLS CUI [1])
    C1389175 (UMLS CUI [2])
    2-6 migraine attacks per month in the three months prior to screening
    Item
    Subject has experienced 2-6 migraine attacks per month in the three months prior to screening
    boolean
    C0149931 (UMLS CUI [1,1])
    C1304680 (UMLS CUI [1,2])
    C0439507 (UMLS CUI [1,3])
    Moderate to Severe Migraine Pain
    Item
    Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
    boolean
    C2957106 (UMLS CUI [1,1])
    C0149931 (UMLS CUI [1,2])
    C0018681 (UMLS CUI [2,1])
    C0205081 (UMLS CUI [2,2])
    C0149931 (UMLS CUI [2,3])
    Able to distinguish between mild migraine pain and other headache types
    Item
    Subject is able to distinguish between mild migraine pain and other headache types
    boolean
    C0162340 (UMLS CUI [1,1])
    C0278138 (UMLS CUI [1,2])
    C0149931 (UMLS CUI [1,3])
    C0018681 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [1,5])
    Able to read, comprehend and complete subject diaries
    Item
    Subject is able to read, comprehend and complete subject diaries and understand that they must treat their migraine during the mild pain phase.
    boolean
    C0586740 (UMLS CUI [1])
    C0162340 (UMLS CUI [2])
    C0584993 (UMLS CUI [3])
    C1321605 (UMLS CUI [4])
    Able and willing to give written informed consent to participate in the study
    Item
    Subject is able and willing to give written informed consent to participate in the study.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    ischemic heart disease, Prinzmetal ’ s angina/coronary vasospasm, or signs/symptoms consistent with any of the above
    Item
    Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal ’ s angina/coronary vasospasm, or signs/symptoms consistent with any of the above.
    boolean
    C0010068 (UMLS CUI [1])
    C0151744 (UMLS CUI [2])
    C0085616 (UMLS CUI [3])
    C0002963 (UMLS CUI [4])
    Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud ’ s Syndrome
    Item
    Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud ’ s Syndrome
    boolean
    C0034734 (UMLS CUI [1])
    C1881056 (UMLS CUI [2])
    C0853812 (UMLS CUI [3])
    cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality
    Item
    Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator ’ s opinion, contraindicates participation in this study.
    boolean
    C1832603 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C0003811 (UMLS CUI [2,1])
    C0332121 (UMLS CUI [2,2])
    history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs)
    Item
    Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).
    boolean
    C0038454 (UMLS CUI [1])
    C0007787 (UMLS CUI [2])
    history of congenital heart disease
    Item
    Subject has a history of congenital heart disease.
    boolean
    C0152021 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    uncontrolled hypertension
    Item
    Subject has uncontrolled hypertension at screening (sitting systolic pressure > 160mmHg, diastolic pressure > 95mmHg).
    boolean
    C1868885 (UMLS CUI [1])
    unrecognized cardiovascular or cerebrovascular disease, e.g. Hypertension, Hypercholestrinemia, smoker, obesity, diabetes, family history of CAD, female in menopause, male over 40
    Item
    Subject, in the investigator ’ s opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (including but is not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age)
    boolean
    C0007222 (UMLS CUI [1,1])
    C4288068 (UMLS CUI [1,2])
    C0007820 (UMLS CUI [2,1])
    C4288068 (UMLS CUI [2,2])
    C0020538 (UMLS CUI [3])
    C0020443 (UMLS CUI [4])
    C0543414 (UMLS CUI [5])
    C0028754 (UMLS CUI [6])
    C0011849 (UMLS CUI [7])
    C2317524 (UMLS CUI [8])
    C0086287 (UMLS CUI [9,1])
    C0025320 (UMLS CUI [9,2])
    C0086582 (UMLS CUI [10,1])
    C0001779 (UMLS CUI [10,2])
    history of epilepsy or structural brain lesions
    Item
    Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening
    boolean
    C0014544 (UMLS CUI [1])
    C0851391 (UMLS CUI [2])
    Subject has basilar (ICHD-II 1.2.6) or hemiplegic (ICHD-II 1.2.4) migraine.
    Item
    Subject has basilar (ICHD-II 1.2.6) or hemiplegic (ICHD-II 1.2.4) migraine.
    boolean
    C0270860 (UMLS CUI [1])
    C0270862 (UMLS CUI [2])
    impaired hepatic or renal function
    Item
    Subject has a history of impaired hepatic or renal function that, in the investigator ’ s opinion, contraindicates participation in this study
    boolean
    C0086565 (UMLS CUI [1])
    C1565489 (UMLS CUI [2])
    Subject has had headache > 15 days/month in either of the three months prior to screening
    Item
    Subject has had headache > 15 days/month in either of the three months prior to screening
    boolean
    C0018681 (UMLS CUI [1,1])
    C0556971 (UMLS CUI [1,2])
    Subject has < 15 days/month of headache-free days in either of the three months prior to screening
    Item
    Subject has < 15 days/month of headache-free days in either of the three months prior to screening
    boolean
    C3843208 (UMLS CUI [1,1])
    C0556971 (UMLS CUI [1,2])
    monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment
    Item
    Subject is currently taking a monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment
    boolean
    C0087111 (UMLS CUI [1,1])
    C0026457 (UMLS CUI [1,2])
    migraine prophylactic medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide
    Item
    Subject is currently taking or has taken in the previous three months, a migraine prophylactic medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide
    boolean
    C0420172 (UMLS CUI [1])
    C0025842 (UMLS CUI [2])
    C0012291 (UMLS CUI [3])
    C0014710 (UMLS CUI [4])
    Subject is currently taking any anti-coagulant (e.g., Coumadin).
    Item
    Subject is currently taking any anti-coagulant (e.g., Coumadin).
    boolean
    C0699129 (UMLS CUI [1])
    C0003280 (UMLS CUI [2])
    herbal preparations containing St. John ’ s Wort
    Item
    Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John ’ s Wort (Hypericum perforatum)
    boolean
    C0936242 (UMLS CUI [1,1])
    C0332256 (UMLS CUI [1,2])
    C1360419 (UMLS CUI [1,3])
    hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium
    Item
    Subject has hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of its components or any other 5-HT 1 receptor agonist.
    boolean
    C0337443 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    C1301624 (UMLS CUI [1,3])
    C0075632 (UMLS CUI [1,4])
    C0027396 (UMLS CUI [1,5])
    History of Allergic Reactions to Naproxen or NSAID induced Asthma, Rhinits and Nasal Polyps
    Item
    Subject has a history of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, and nasal polyps.
    boolean
    C2106654 (UMLS CUI [1])
    C2106654 (UMLS CUI [2,1])
    C0004057 (UMLS CUI [2,2])
    C2106654 (UMLS CUI [3,1])
    C0027396 (UMLS CUI [3,2])
    C2106654 (UMLS CUI [4,1])
    C0003211 (UMLS CUI [4,2])
    C0004096 (UMLS CUI [5])
    C0035455 (UMLS CUI [6])
    C0027430 (UMLS CUI [7])
    History of Gastrointestinal Surgery that Indicates History of Bleeding, Ulceration or Perforation
    Item
    Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
    boolean
    C0524722 (UMLS CUI [1])
    C1963975 (UMLS CUI [2])
    C0017181 (UMLS CUI [3])
    C0151664 (UMLS CUI [4])
    C0262926 (UMLS CUI [5])
    Subject has a history of gastric bypass or stapling surgery
    Item
    Subject has a history of gastric bypass or stapling surgery
    boolean
    C0017125 (UMLS CUI [1])
    C0543467 (UMLS CUI [2])
    GI ulceration in the past six months or gastrointestinal bleeding in the past year
    Item
    Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
    boolean
    C0237938 (UMLS CUI [1,1])
    C4086728 (UMLS CUI [1,2])
    C0017181 (UMLS CUI [2,1])
    C3828652 (UMLS CUI [2,2])
    Subject has a history of inflammatory bowel disease
    Item
    Subject has a history of inflammatory bowel disease
    boolean
    C0021390 (UMLS CUI [1])
    Subject has a history of any bleeding disorder
    Item
    Subject has a history of any bleeding disorder
    boolean
    C0005779 (UMLS CUI [1])
    antiplatelet agent
    Item
    Subject is taking any antiplatelet agent (except low-dose aspirin < 325 mg/day for cardioprotective reasons).
    boolean
    C1096021 (UMLS CUI [1,1])
    C0332300 (UMLS CUI [1,2])
    C0004057 (UMLS CUI [1,3])
    C0445550 (UMLS CUI [1,4])
    Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
    Item
    Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
    boolean
    C0003015 (UMLS CUI [1])
    C0521942 (UMLS CUI [2])
    Subject is pregnant, actively trying to become pregnant or breast-feeding
    Item
    Subject is pregnant, actively trying to become pregnant or breast-feeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    alcohol or substance abuse
    Item
    Subject has evidence of alcohol or substance abuse within the last year which, in the investigator's judgement, will likely interfere with the study conduct, subject co-operation, or evaluation and interpretation of the study results
    boolean
    C0085762 (UMLS CUI [1])
    C0038586 (UMLS CUI [2])
    concurrent medical or psychiatric condition
    Item
    Subject has any concurrent medical or psychiatric condition which, in the investigator's opinion, may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in this clinical trial.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0004936 (UMLS CUI [2])
    Investigational drug trial within the previous four weeks
    Item
    Subject has participated in an investigational drug trial within the previous four weeks (excepting a previous study evaluating Trexima in which case an interval of at least 7 days have elapsed since discharge from previous Trexima trial), or plans to participate in another study at any time during this study
    boolean
    C2348568 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
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