ID

34059

Beskrivning

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.

Länk

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

Nyckelord

Versioner (6)
  1. 2018-06-20 2018-06-20 - Halim Ugurlu
  2. 2019-01-11 2019-01-11 -
  3. 2019-01-13 2019-01-13 -
  4. 2019-01-18 2019-01-18 -
  5. 2019-01-18 2019-01-18 - Sarah Riepenhausen
  6. 2021-09-20 2021-09-20 -
Rättsinnehavare

GlaxoSmithKline (GSK)

Uppladdad den

13 januari 2019

DOI

För en begäran logga in.

Licens

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

Eligibility Criteria

1 Formulär  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Information
Beskrivning

Administrative Information

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beskrivning

Centre Number

Datatyp

text

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

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility Question
Beskrivning

Eligibility Question

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

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.

Datatyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beskrivning

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.
Beskrivning

Age

Datatyp

boolean

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

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.

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

Moderate to severe migraine pain

Datatyp

boolean

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

Able to distinguish between mild migraine pain and other headache types

Datatyp

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.
Beskrivning

Able to read, comprehend and complete subject diaries

Datatyp

boolean

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

boolean

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

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034734
UMLS CUI [1,2]
C0007787
UMLS CUI [1,3]
C1881056
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.
Beskrivning

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

Datatyp

boolean

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

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

Datatyp

boolean

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

history of congenital heart disease

Datatyp

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).
Beskrivning

uncontrolled hypertension

Datatyp

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)
Beskrivning

unrecognized cardiovascular or cerebrovascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0038454
UMLS CUI [2,2]
C4288068
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
Beskrivning

history of epilepsy or structural brain lesions

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

impaired hepatic or renal function

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

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

Datatyp

boolean

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

herbal preparations containing St. John ’ s Wort

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0936242
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0013227
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.
Beskrivning

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

Datatyp

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.
Beskrivning

history of allergic reactions

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2106654
UMLS CUI [1,3]
C0004057
UMLS CUI [1,4]
C0027396
UMLS CUI [1,5]
C0003211
Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
Beskrivning

history of any gastrointestinal surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524722
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C1963975
UMLS CUI [1,4]
C0017181
UMLS CUI [1,5]
C0151664
UMLS CUI [1,6]
C0262926
Subject has a history of gastric bypass or stapling surgery
Beskrivning

Subject has a history of gastric bypass or stapling surgery

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Subject has a history of inflammatory bowel disease

Datatyp

boolean

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

Subject has a history of any bleeding disorder

Datatyp

boolean

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

antiplatelet agent

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
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
Beskrivning

alcohol or substance abuse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
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.
Beskrivning

concurrent medical or psychiatric condition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
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
Beskrivning

Investigational drug trial within the previous four weeks

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Criteria

1 Formulär
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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 [1,1])
C0162340 (UMLS CUI [1,2])
C0584993 (UMLS CUI [1,3])
C1321605 (UMLS CUI [1,4])
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 [1,1])
C0151744 (UMLS CUI [1,2])
C0085616 (UMLS CUI [1,3])
C0002963 (UMLS CUI [1,4])
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 [1,1])
C0007787 (UMLS CUI [1,2])
C1881056 (UMLS CUI [1,3])
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])
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 [1,1])
C0007787 (UMLS CUI [1,2])
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
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])
C0038454 (UMLS CUI [2,1])
C4288068 (UMLS CUI [2,2])
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 [1,1])
C0025842 (UMLS CUI [1,2])
C0012291 (UMLS CUI [1,3])
C0014710 (UMLS CUI [1,4])
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 [1,1])
C0003280 (UMLS CUI [1,2])
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])
C0013227 (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
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
C0020517 (UMLS CUI [1,1])
C2106654 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0027396 (UMLS CUI [1,4])
C0003211 (UMLS CUI [1,5])
history of any gastrointestinal surgery
Item
Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
boolean
C0524722 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1963975 (UMLS CUI [1,3])
C0017181 (UMLS CUI [1,4])
C0151664 (UMLS CUI [1,5])
C0262926 (UMLS CUI [1,6])
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 [1,1])
C0543467 (UMLS CUI [1,2])
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 [1,1])
C0521942 (UMLS CUI [1,2])
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 [1,1])
C0006147 (UMLS CUI [1,2])
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 [1,1])
C0038586 (UMLS CUI [1,2])
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 [1,3])
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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