ID

44360

Description

This ODM-file contains the eligibility criteria. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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

Keywords

Versions (4)
  1. 10/28/18 10/28/18 -
  2. 10/29/18 10/29/18 -
  3. 10/30/18 10/30/18 -
  4. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Eligibility Question
Description

Eligibility Question

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

If No, ✔ 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

Data type

text

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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.
Description

Gender; Female of non-childbearing potential or negative pregnancy testing and willing to use specific contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0086287
UMLS CUI [2,2]
C3831118
UMLS CUI [3,1]
C0086287
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0427780
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).
Description

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)

Data type

boolean

Alias
UMLS CUI [1,1]
C3808875
UMLS CUI [1,2]
C0679228
UMLS CUI [2,1]
C3808875
UMLS CUI [2,2]
C0008902
UMLS CUI [2,3]
C0018681
Subject has experienced 2-6 migraine attacks per month in the three months prior to screening.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C1304680
UMLS CUI [1,3]
C0332177
Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
Description

Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.

Data type

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C1320357
UMLS CUI [2,1]
C0149931
UMLS CUI [2,2]
C0278138
UMLS CUI [2,3]
C0205390
Subject is able to distinguish between mild migraine pain and other headache types.
Description

Ability to distinguish between mild migraine pain and other headache types

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0205235
UMLS CUI [1,3]
C0149931
UMLS CUI [1,4]
C0018681
Subject is able to read, comprehend and complete subject diaries and understand that they must treat their migraine during the mild pain phase.
Description

Ability to read, comprehend and complete subject diaries; treatment of the migraine during the mild pain phase

Data type

boolean

Alias
UMLS CUI [1]
C0586740
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C1321605
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0149931
UMLS CUI [3,3]
C0347984
UMLS CUI [3,4]
C0278138
Subject is able and willing to give written informed consent to participate in the study.
Description

Ability and willingness to give written informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0600109
Exclusion Criteria
Description

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
Description

Confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm

Data type

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0340291
UMLS CUI [5]
C0002963
UMLS CUI [6]
C0010073
Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome.
Description

Evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome.

Data type

boolean

Alias
UMLS CUI [1]
C0085096
UMLS CUI [2]
C0034734
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.
Description

Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating a study participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0332121
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C0522473
UMLS CUI [2,4]
C2348568
Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).
Description

Cerebrovascular pathology including stroke and/or transient ischemic attacks

Data type

boolean

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

Congenital heart disease

Data type

boolean

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

Uncontrolled hypertension at screening

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1409616
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).
Description

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)

Data type

boolean

Alias
UMLS CUI [1,1]
C4288068
UMLS CUI [1,2]
C0007222
UMLS CUI [2,1]
C4288068
UMLS CUI [2,2]
C0007820
UMLS CUI [3]
C0020538
UMLS CUI [4]
C0020443
UMLS CUI [5]
C0337664
UMLS CUI [6]
C0028754
UMLS CUI [7]
C0011849
UMLS CUI [8]
C2317524
UMLS CUI [9]
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.
Description

Epilepsy or structural brain lesions lowering the convulsive threshold or treatment with an antiepileptic drug within 5 years prior to screening

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0221505
UMLS CUI [2,2]
C0234976
UMLS CUI [3,1]
C0003299
UMLS CUI [3,2]
C0332185
Subject has basilar (ICHD-II 1.2.6) or hemiplegic (ICHD-II 1.2.4) migraine.
Description

Basilar (ICHD-II 1.2.6) or hemiplegic (ICHD-II 1.2.4) migraine

Data type

boolean

Alias
UMLS CUI [1,1]
C0270860
UMLS CUI [1,2]
C0008902
UMLS CUI [1,3]
C0018681
UMLS CUI [2,1]
C0270862
UMLS CUI [2,2]
C0008902
UMLS CUI [2,3]
C0018681
Subject has a history of impaired hepatic or renal function that, in the investigator’s opinion, contraindicates participation in this study.
Description

Impairment of hepatic or renal function contraindication a participation in this study

Data type

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0522473
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0522473
UMLS CUI [2,3]
C2348568
Subject has had headache >15 days/month in either of the three months prior to screening.
Description

Headache > 15 days/month recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0556971
UMLS CUI [1,3]
C0332185
Subject has <15 days/month of headache-free days in either of the three months prior to screening.
Description

< 15 days/month of headache-free days recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0556971
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0018681
UMLS CUI [1,4]
C0332185
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.
Description

Current or recent treatment with a monoamine oxidase inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0026457
UMLS CUI [1,2]
C2827774
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
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.
Description

Current or recent medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide

Data type

boolean

Alias
UMLS CUI [1,1]
C2827774
UMLS CUI [1,2]
C0012291
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0012291
UMLS CUI [3,1]
C2827774
UMLS CUI [3,2]
C0014710
UMLS CUI [4,1]
C0332185
UMLS CUI [4,2]
C0014710
UMLS CUI [5,1]
C2827774
UMLS CUI [5,2]
C0025842
UMLS CUI [6,1]
C0332185
UMLS CUI [6,2]
C0025842
Subject is currently taking any anti-coagulant (e.g., Coumadin).
Description

Currently taking any anti-coagulant (e.g., Coumadin)

Data type

boolean

Alias
UMLS CUI [1,1]
C2827774
UMLS CUI [1,2]
C0003280
UMLS CUI [2]
C0699129
Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John’s Wort (Hypericum perforatum).
Description

Current or recent intake of herbal preparations containing St. John's Wort (Hypericum perforatum)

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C1360419
UMLS CUI [1,3]
C0936242
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C1360419
UMLS CUI [2,3]
C0936242
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.
Description

Hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of its components or any other 5-HT1 receptor agonist.

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0075632
UMLS CUI [2,1]
C0277585
UMLS CUI [2,2]
C0075632
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0075632
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0546873
UMLS CUI [5,1]
C0277585
UMLS CUI [5,2]
C0546873
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0546873
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0162754
UMLS CUI [8,1]
C0277585
UMLS CUI [8,2]
C0162754
UMLS CUI [9,1]
C1301624
UMLS CUI [9,2]
C0162754
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.
Description

History of allergic reactions to naproxen preparations, including the syndrome of asthma, rhinitis, and nasal polyps due to aspirin or other NSAID drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0027396
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0004096
UMLS CUI [2,3]
C0035455
UMLS CUI [2,4]
C0027430
UMLS CUI [3,1]
C0004057
UMLS CUI [3,2]
C0004096
UMLS CUI [3,3]
C0035455
UMLS CUI [3,4]
C0027430
Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
Description

History of gastrointestinal surgery specifically indicating a past history of bleeding, ulceration or perforation

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0524722
UMLS CUI [1,3]
C1963975
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0524722
UMLS CUI [2,3]
C0017181
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0524722
UMLS CUI [3,3]
C0151664
Subject has a history of gastric bypass or stapling surgery.
Description

History of gastric bypass or stapling surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0017125
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0149701
UMLS CUI [2,2]
C0262926
Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
Description

Recent history of GI ulceration or gastrointestinal bleeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0237938
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0017181
UMLS CUI [2,2]
C0332185
Subject has a history of inflammatory bowel disease.
Description

History of inflammatory bowel disease

Data type

boolean

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

History of any bleeding disorder

Data type

boolean

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

Intake of any antiplatelet agent (except low-dose aspirin <325 mg/day for cardioprotective reasons)

Data type

boolean

Alias
UMLS CUI [1,1]
C0085826
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C2608320
Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
Description

Intake of any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker

Data type

boolean

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

Pregnancy, actively trying to become pregnant or breast-feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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
Description

Evidence of alcohol or substance abuse within the last year which will likely interfere with the study

Data type

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2603343
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2603343
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.
Description

Concurrent medical or psychiatric condition which may affect the study interpretation or otherwise contraindicates a participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1264692
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1264692
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C2348568
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.
Description

Recent or planned participation in an investigational drug trial, excepting a previous study evaluating Trexima more than 7 days ago

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C1724412
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Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C0013893 (UMLS CUI [1])
Did the subject meet all the entry criteria?
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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])
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