ID

42672

Description

This form contains the eligibility criteria. To be assessed at screening. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Other Eligibility Criteria Considerations To assess any potential impact on subject eligibility with regard to safety, the investigator must refer to the following document(s) for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the investigational product(s) being used in this study: approved product label for IMITREX injection and tablets, approved product label for naproxen sodium tablets and CIB for the combination product (sumatriptan/naproxen sodium).

Link

https://clinicaltrials.gov/ct2/show/NCT00875784

Keywords

Versions (3)
  1. 11/17/18 11/17/18 -
  2. 11/21/18 11/21/18 -
  3. 9/17/21 9/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784

English

Eligibility Criteria

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

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

Eligibility

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
Healthy, non-smoking (within 30 days of screening), adult males and females between 18 and 55 years of age, inclusive.
Description

Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies and other tests.

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C1519386
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0079399
Female subjects are eligible for participation in the study if they are of: a Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b Childbearing potential, have a negative pregnancy test (urine or serum) at screening, one of the following applies: • Agree to complete abstinence from intercourse for at least 14 days prior to first dose of study medication, throughout the study, and for a time interval after completion of the study or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 3 days); 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 criteria); or, • Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm); or, • Any other barrier methods (only if used in combination with any of the above acceptable methods); or, • Any other method with published data showing that the lowest expected failure rate is less than 1percent per year.
Description

Females of non-childbearing potential or of childbearing potential with negative pregnancy test and using certain contraceptive method(s)

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0427780
Any subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening.
Description

Stable regimen of oral contraceptives

Data type

boolean

Alias
UMLS CUI [1,1]
C0009905
UMLS CUI [1,2]
C0237125
UMLS CUI [1,3]
C0205360
BMI: 20-32 kg/m2 , inclusive.
Description

BMI: 20-32 kg/m2

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Subject has a QTc <450 msec or <480 msec if associated with bundle branch block
Description

QTc <450 msec or <480 msec if associated with bundle branch block

Data type

boolean

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0006384
Subject is willing and able to provide written informed consent.
Description

Willing and able to provide written informed consent

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Subjects who suffer from migraine attacks.
Description

Migraine attacks

Data type

boolean

Alias
UMLS CUI [1]
C0149931
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 [1,1]
C0002962
UMLS CUI [1,2]
C0750491
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0750484
UMLS CUI [3,1]
C0027051
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C0750484
UMLS CUI [5,1]
C0340291
UMLS CUI [5,2]
C0750491
UMLS CUI [6,1]
C0340291
UMLS CUI [6,2]
C0750484
UMLS CUI [7,1]
C0002963
UMLS CUI [7,2]
C0750491
UMLS CUI [8,1]
C0002963
UMLS CUI [8,2]
C0750484
Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s syndrome.
Description

Ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0034734
UMLS CUI [2]
C0085096
UMLS CUI [3,1]
C0022116
UMLS CUI [3,2]
C0000726
Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram (ECG) 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 the study participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C1301624
UMLS CUI [2,4]
C2348568
Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).
Description

History of cerebrovascular pathology including stroke and/or transient ischemic attacks

Data type

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0559159
UMLS CUI [3]
C0007787
Subject has a history of congenital heart disease.
Description

Congenital heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0152021
Subject has hypertension at screening (sitting systolic pressure ≥140mmHg, diastolic pressure ≥90mmHg).
Description

Hypertension at screening

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
Subject, in the investigator’s opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to hypertension, hypercholesterolemia, prior smoking history, 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. risk factors such as hypertension, hypercholesterolemia, prior smoking history, 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]
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]
C1519384
UMLS CUI [6]
C0028754
UMLS CUI [7]
C0011849
UMLS CUI [8,1]
C0241889
UMLS CUI [8,2]
C1956346
UMLS CUI [9,1]
C0086287
UMLS CUI [9,2]
C0025320
UMLS CUI [10,1]
C0001779
UMLS CUI [10,2]
C0086582
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

History of epilepsy or structural brain lesions lowering the convulsive threshold or recent treatment with an antiepileptic drug

Data type

boolean

Alias
UMLS CUI [1]
C0455511
UMLS CUI [2,1]
C0221505
UMLS CUI [2,2]
C0234976
UMLS CUI [3,1]
C0003299
UMLS CUI [3,2]
C0332185
History of impaired hepatic or renal function.
Description

History of impaired hepatic or renal function

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John’s Wort (Hypericum perforatum).
Description

Herbal preparations containing St. John's Wort (Hypericum perforatum) currently or recently taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C1360419
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0936242
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C1360419
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0936242
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication. Note: Excluded from this list are: acetaminophen at doses of ≤ 2 grams/day and contraceptives.
Description

Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, excluded acetaminophen at certain doses and contraceptives

Data type

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0304227
UMLS CUI [3]
C0042890
UMLS CUI [4]
C1504473
UMLS CUI [5]
C0242295
UMLS CUI [6,1]
C0332300
UMLS CUI [6,2]
C0000970
UMLS CUI [7,1]
C0332300
UMLS CUI [7,2]
C0009871
Subject has a hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of their components or any other 5-HT1 receptor agonist.
Description

History of hypersensitivity, intolerance or contraindication to the use of sumatriptan or naproxen sodium or any of their components or aspirin 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]
C0027396
UMLS CUI [5,1]
C0277585
UMLS CUI [5,2]
C0027396
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0027396
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0027396
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0004057
UMLS CUI [9,1]
C0277585
UMLS CUI [9,2]
C0004057
UMLS CUI [10,1]
C1301624
UMLS CUI [10,2]
C0004057
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0162754
UMLS CUI [12,1]
C0277585
UMLS CUI [12,2]
C0162754
UMLS CUI [13,1]
C1301624
UMLS CUI [13,2]
C0162754
Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
Description

Gastrointestinal surgery due to bleeding, ulceration or perforation

Data type

boolean

Alias
UMLS CUI [1,1]
C1963975
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C0017181
UMLS CUI [2,2]
C0543467
UMLS CUI [3,1]
C0151664
UMLS CUI [3,2]
C0543467
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]
C0149701
UMLS CUI [2]
C0017125
Subject has a history of GI ulceration or gastrointestinal bleeding.
Description

History of GI ulceration or gastrointestinal bleeding

Data type

boolean

Alias
UMLS CUI [1]
C1963975
UMLS CUI [2]
C0017181
Subject has a history of inflammatory bowel disease.
Description

History of inflammatory bowel disease

Data type

boolean

Alias
UMLS CUI [1]
C0021390
Treatment with an investigational drug within 30 days preceding the first dose of study medication.
Description

Recent treatment with an investigational drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332185
Positive beta-human chorionic gonadotropin (beta-hCG) test (females).
Description

Positive serum beta-hCG test (females)

Data type

boolean

Alias
UMLS CUI [1,1]
C1255526
UMLS CUI [1,2]
C1446409
UMLS CUI [1,3]
C0086287
Pregnant, actively trying to become pregnant or breast-feeding.
Description

Pregnant, actively trying to become pregnant or breast-feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
Subjects with a history of drug or alcohol abuse.
Description

History of drug or alcohol abuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0038586
History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Description

Regular Alcohol consumption as measured by alcohol units/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
UMLS CUI [2]
C0560579
Positive urine drug screen (UDS) including alcohol at screening.
Description

Positive urine drug screening including alcohol

Data type

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C1112219
Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result or positive HIV result within 3 months of screening.
Description

Infection status of hepatitis B, hepatitis C and HIV

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication
Description

Donation of blood

Data type

boolean

Alias
UMLS CUI [1]
C0005794
Subject has a history of tobacco use within 30 days of screening.
Description

Recent use of tobacco

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0332185
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof.
Description

History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity the study medications or components

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0019134
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0272285
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1521826
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Similar models

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)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Eligibility
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Healthy, non-smoking adult males and femals between 18 and 55 years
Item
Healthy, non-smoking (within 30 days of screening), adult males and females between 18 and 55 years of age, inclusive.
boolean
C3898900 (UMLS CUI [1])
C1519386 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Females of non-childbearing potential or of childbearing potential with negative pregnancy test and using certain contraceptive method(s)
Item
Female subjects are eligible for participation in the study if they are of: a Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b Childbearing potential, have a negative pregnancy test (urine or serum) at screening, one of the following applies: • Agree to complete abstinence from intercourse for at least 14 days prior to first dose of study medication, throughout the study, and for a time interval after completion of the study or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 3 days); 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 criteria); or, • Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm); or, • Any other barrier methods (only if used in combination with any of the above acceptable methods); or, • Any other method with published data showing that the lowest expected failure rate is less than 1percent per year.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0427780 (UMLS CUI [3])
Stable regimen of oral contraceptives
Item
Any subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening.
boolean
C0009905 (UMLS CUI [1,1])
C0237125 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
BMI: 20-32 kg/m2
Item
BMI: 20-32 kg/m2 , inclusive.
boolean
C1305855 (UMLS CUI [1])
QTc <450 msec or <480 msec if associated with bundle branch block
Item
Subject has a QTc <450 msec or <480 msec if associated with bundle branch block
boolean
C0489625 (UMLS CUI [1,1])
C0006384 (UMLS CUI [1,2])
Willing and able to provide written informed consent
Item
Subject is willing and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Migraine attacks
Item
Subjects who suffer from migraine attacks.
boolean
C0149931 (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
C0002962 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0750484 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4,1])
C0750484 (UMLS CUI [4,2])
C0340291 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0340291 (UMLS CUI [6,1])
C0750484 (UMLS CUI [6,2])
C0002963 (UMLS CUI [7,1])
C0750491 (UMLS CUI [7,2])
C0002963 (UMLS CUI [8,1])
C0750484 (UMLS CUI [8,2])
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])
C0085096 (UMLS CUI [2])
C0022116 (UMLS CUI [3,1])
C0000726 (UMLS CUI [3,2])
Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating the study participation
Item
Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram (ECG) abnormality that, in the investigator’s opinion, contraindicates participation in this study.
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0522055 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C1301624 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
History of 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
C0007820 (UMLS CUI [1])
C0559159 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Congenital heart disease
Item
Subject has a history of congenital heart disease.
boolean
C0152021 (UMLS CUI [1])
Hypertension at screening
Item
Subject has hypertension at screening (sitting systolic pressure ≥140mmHg, diastolic pressure ≥90mmHg).
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Likely to have unrecognized cardiovascular or cerebrovascular disease (e.g. risk factors such as hypertension, hypercholesterolemia, prior smoking history, 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 (based on history or the presence of risk factors including but not limited to hypertension, hypercholesterolemia, prior smoking history, 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])
C1519384 (UMLS CUI [5])
C0028754 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
C0241889 (UMLS CUI [8,1])
C1956346 (UMLS CUI [8,2])
C0086287 (UMLS CUI [9,1])
C0025320 (UMLS CUI [9,2])
C0001779 (UMLS CUI [10,1])
C0086582 (UMLS CUI [10,2])
History of epilepsy or structural brain lesions lowering the convulsive threshold or recent treatment with an antiepileptic drug
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
C0455511 (UMLS CUI [1])
C0221505 (UMLS CUI [2,1])
C0234976 (UMLS CUI [2,2])
C0003299 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
History of impaired hepatic or renal function
Item
History of impaired hepatic or renal function.
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Herbal preparations containing St. John's Wort (Hypericum perforatum) currently or recently taken
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])
C0332256 (UMLS CUI [1,3])
C0936242 (UMLS CUI [1,4])
C0332185 (UMLS CUI [2,1])
C1360419 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0936242 (UMLS CUI [2,4])
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, excluded acetaminophen at certain doses and contraceptives
Item
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication. Note: Excluded from this list are: acetaminophen at doses of ≤ 2 grams/day and contraceptives.
boolean
C0013231 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
C0332300 (UMLS CUI [6,1])
C0000970 (UMLS CUI [6,2])
C0332300 (UMLS CUI [7,1])
C0009871 (UMLS CUI [7,2])
History of hypersensitivity, intolerance or contraindication to the use of sumatriptan or naproxen sodium or any of their components or aspirin or any other 5-HT1 receptor agonist.
Item
Subject has a hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of their 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])
C0027396 (UMLS CUI [4,2])
C0277585 (UMLS CUI [5,1])
C0027396 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0027396 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0027396 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0004057 (UMLS CUI [8,2])
C0277585 (UMLS CUI [9,1])
C0004057 (UMLS CUI [9,2])
C1301624 (UMLS CUI [10,1])
C0004057 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0162754 (UMLS CUI [11,2])
C0277585 (UMLS CUI [12,1])
C0162754 (UMLS CUI [12,2])
C1301624 (UMLS CUI [13,1])
C0162754 (UMLS CUI [13,2])
Gastrointestinal surgery due to 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
C1963975 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0151664 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
History of gastric bypass or stapling surgery
Item
Subject has a history of gastric bypass or stapling surgery.
boolean
C0149701 (UMLS CUI [1])
C0017125 (UMLS CUI [2])
History of GI ulceration or gastrointestinal bleeding
Item
Subject has a history of GI ulceration or gastrointestinal bleeding.
boolean
C1963975 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
History of inflammatory bowel disease
Item
Subject has a history of inflammatory bowel disease.
boolean
C0021390 (UMLS CUI [1])
Recent treatment with an investigational drug
Item
Treatment with an investigational drug within 30 days preceding the first dose of study medication.
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Positive serum beta-hCG test (females)
Item
Positive beta-human chorionic gonadotropin (beta-hCG) test (females).
boolean
C1255526 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0086287 (UMLS CUI [1,3])
Pregnant, actively trying to become pregnant or breast-feeding
Item
Pregnant, actively trying to become pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
History of drug or alcohol abuse
Item
Subjects with a history of drug or alcohol abuse.
boolean
C0262926 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
Regular Alcohol consumption as measured by alcohol units/week
Item
History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0560579 (UMLS CUI [2])
Positive urine drug screening including alcohol
Item
Positive urine drug screen (UDS) including alcohol at screening.
boolean
C0743300 (UMLS CUI [1])
C1112219 (UMLS CUI [2])
Infection status of hepatitis B, hepatitis C and HIV
Item
Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result or positive HIV result within 3 months of screening.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Donation of blood
Item
Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication
boolean
C0005794 (UMLS CUI [1])
Recent use of tobacco
Item
Subject has a history of tobacco use within 30 days of screening.
boolean
C0543414 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity the study medications or components
Item
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof.
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0272285 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1521826 (UMLS CUI [3,2])
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