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])
Gender; Female of non-childbearing potential or negative pregnancy testing and willing to use specific contraceptive methods
Item
Subject is male or female. 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 1percent 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 1percent per year.
boolean
C0079399 (UMLS CUI [1])
C0086287 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0086287 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0427780 (UMLS CUI [3,3])
At least a 6 month history that meets 2004 IHC Criteria for migraine with aura (ICHD-II 1.2.1) or migraine without aura (ICHD-II 1.1)
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
C3808875 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
C3808875 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
C0018681 (UMLS CUI [2,3])
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])
C0332177 (UMLS CUI [1,3])
Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
Item
Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
boolean
C0149931 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
C0149931 (UMLS CUI [2,1])
C0278138 (UMLS CUI [2,2])
C0205390 (UMLS CUI [2,3])
Ability 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
C0085732 (UMLS CUI [1,1])
C0205235 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,4])
Ability to read, comprehend and complete subject diaries; treatment of the migraine during the mild pain phase
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 [2,1])
C1321605 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0149931 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C0278138 (UMLS CUI [3,4])
Ability and willingness to give written informed consent
Item
Subject is able and willing to give written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm
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
C0151744 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
C0002963 (UMLS CUI [5])
C0010073 (UMLS CUI [6])
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
C0085096 (UMLS CUI [1])
C0034734 (UMLS CUI [2])
C0853812 (UMLS CUI [3])
Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating a study participation
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
C0003811 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0522055 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C0522473 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Cerebrovascular pathology including stroke and/or transient ischemic attacks
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])
Congenital heart disease
Item
Subject has a history of congenital heart disease.
boolean
C0152021 (UMLS CUI [1])
Uncontrolled hypertension at screening
Item
Subject has uncontrolled hypertension at screening (sitting systolic pressure >160mmHg, diastolic pressure >95mmHg).
boolean
C1868885 (UMLS CUI [1,1])
C1409616 (UMLS CUI [1,2])
Likely to have unrecognized cardiovascular or cerebrovascular disease (e.g. 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)
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
C4288068 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
C4288068 (UMLS CUI [2,1])
C0007820 (UMLS CUI [2,2])
C0020538 (UMLS CUI [3])
C0020443 (UMLS CUI [4])
C0337664 (UMLS CUI [5])
C0028754 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
C2317524 (UMLS CUI [8])
C0025320 (UMLS CUI [9])
C0086582 (UMLS CUI [10,1])
C0001779 (UMLS CUI [10,2])
Epilepsy or structural brain lesions lowering the convulsive threshold or treatment with an antiepileptic drug within 5 years prior to screening
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])
C0221505 (UMLS CUI [2,1])
C0234976 (UMLS CUI [2,2])
C0003299 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
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 [1,1])
C0008902 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,3])
C0270862 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
C0018681 (UMLS CUI [2,3])
Impairment of hepatic or renal function contraindication a participation in this study
Item
Subject has a history of impaired hepatic or renal function that, in the investigator’s opinion, contraindicates participation in this study.
boolean
C0948807 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1565489 (UMLS CUI [2,1])
C0522473 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Headache > 15 days/month recently
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])
C0332185 (UMLS CUI [1,3])
< 15 days/month of headache-free days recently
Item
Subject has <15 days/month of headache-free days in either of the three months prior to screening.
boolean
C0556971 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
Current or recent treatment with a monoamine oxidase inhibitor
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
C0026457 (UMLS CUI [1,1])
C2827774 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0026457 (UMLS CUI [2,2])
Current or recent 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
C2827774 (UMLS CUI [1,1])
C0012291 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0012291 (UMLS CUI [2,2])
C2827774 (UMLS CUI [3,1])
C0014710 (UMLS CUI [3,2])
C0332185 (UMLS CUI [4,1])
C0014710 (UMLS CUI [4,2])
C2827774 (UMLS CUI [5,1])
C0025842 (UMLS CUI [5,2])
C0332185 (UMLS CUI [6,1])
C0025842 (UMLS CUI [6,2])
Currently taking any anti-coagulant (e.g., Coumadin)
Item
Subject is currently taking any anti-coagulant (e.g., Coumadin).
boolean
C2827774 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
C0699129 (UMLS CUI [2])
Current or recent intake of herbal preparations containing St. John's Wort (Hypericum perforatum)
Item
Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John’s Wort (Hypericum perforatum).
boolean
C0521116 (UMLS CUI [1,1])
C1360419 (UMLS CUI [1,2])
C0936242 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C1360419 (UMLS CUI [2,2])
C0936242 (UMLS CUI [2,3])
Hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of its components or any other 5-HT1 receptor agonist.
Item
Subject has hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of its components or any other 5-HT1 receptor agonist.
boolean
C0020517 (UMLS CUI [1,1])
C0075632 (UMLS CUI [1,2])
C0277585 (UMLS CUI [2,1])
C0075632 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0075632 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0546873 (UMLS CUI [4,2])
C0277585 (UMLS CUI [5,1])
C0546873 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0546873 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0162754 (UMLS CUI [7,2])
C0277585 (UMLS CUI [8,1])
C0162754 (UMLS CUI [8,2])
C1301624 (UMLS CUI [9,1])
C0162754 (UMLS CUI [9,2])
History of allergic reactions to naproxen preparations, including the syndrome of asthma, rhinitis, and nasal polyps due to aspirin or other NSAID drugs
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
C1527304 (UMLS CUI [1,1])
C0027396 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0035455 (UMLS CUI [2,3])
C0027430 (UMLS CUI [2,4])
C0004057 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C0035455 (UMLS CUI [3,3])
C0027430 (UMLS CUI [3,4])
History of gastrointestinal surgery specifically indicating a past 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
C0262926 (UMLS CUI [1,1])
C0524722 (UMLS CUI [1,2])
C1963975 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0524722 (UMLS CUI [2,2])
C0017181 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0524722 (UMLS CUI [3,2])
C0151664 (UMLS CUI [3,3])
History of gastric bypass or stapling surgery
Item
Subject has a history of gastric bypass or stapling surgery.
boolean
C0017125 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0149701 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Recent history of GI ulceration or gastrointestinal bleeding
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])
C0332185 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
History of inflammatory bowel disease
Item
Subject has a history of inflammatory bowel disease.
boolean
C0021390 (UMLS CUI [1])
History of any bleeding disorder
Item
Subject has a history of any bleeding disorder.
boolean
C0005779 (UMLS CUI [1])
Intake of any antiplatelet agent (except low-dose aspirin <325 mg/day for cardioprotective reasons)
Item
Subject is taking any antiplatelet agent (except low-dose aspirin <325 mg/day for cardioprotective reasons).
boolean
C0085826 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C2608320 (UMLS CUI [1,3])
Intake of 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])
Pregnancy, 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])
C0032992 (UMLS CUI [3])
Evidence of alcohol or substance abuse within the last year which will likely interfere with the study
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 [1,1])
C0521102 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2603343 (UMLS CUI [2,3])
Concurrent medical or psychiatric condition which may affect the study interpretation or otherwise contraindicates a participation
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])
C0521102 (UMLS CUI [1,2])
C1264692 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1264692 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
Recent or planned participation in an investigational drug trial, excepting a previous study evaluating Trexima more than 7 days ago
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])
C0332300 (UMLS CUI [1,3])
C1724412 (UMLS CUI [1,4])