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)
- 11/17/18 11/17/18 -
- 11/21/18 11/21/18 -
- 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
Eligibility Criteria
- StudyEvent: ODM
Description
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C1516637
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
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
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
Description
BMI: 20-32 kg/m2
Data type
boolean
Alias
- UMLS CUI [1]
- C1305855
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
Description
Willing and able to provide written informed consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0600109
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Migraine attacks
Data type
boolean
Alias
- UMLS CUI [1]
- C0149931
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
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
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
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
Description
Congenital heart disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0152021
Description
Hypertension at screening
Data type
boolean
Alias
- UMLS CUI [1]
- C1868885
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C0428883
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
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
Description
History of impaired hepatic or renal function
Data type
boolean
Alias
- UMLS CUI [1]
- C0086565
- UMLS CUI [2]
- C1565489
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
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
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
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
Description
History of gastric bypass or stapling surgery
Data type
boolean
Alias
- UMLS CUI [1]
- C0149701
- UMLS CUI [2]
- C0017125
Description
History of GI ulceration or gastrointestinal bleeding
Data type
boolean
Alias
- UMLS CUI [1]
- C1963975
- UMLS CUI [2]
- C0017181
Description
History of inflammatory bowel disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0021390
Description
Recent treatment with an investigational drug
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332185
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
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
Description
History of drug or alcohol abuse
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0038586
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
Description
Positive urine drug screening including alcohol
Data type
boolean
Alias
- UMLS CUI [1]
- C0743300
- UMLS CUI [2]
- C1112219
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
Description
Donation of blood
Data type
boolean
Alias
- UMLS CUI [1]
- C0005794
Description
Recent use of tobacco
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0332185
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
Similar models
Eligibility Criteria
- StudyEvent: ODM
C1519386 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0700589 (UMLS CUI [2])
C0427780 (UMLS CUI [3])
C0237125 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0006384 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,2])
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])
C0085096 (UMLS CUI [2])
C0022116 (UMLS CUI [3,1])
C0000726 (UMLS CUI [3,2])
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])
C0559159 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
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])
C0221505 (UMLS CUI [2,1])
C0234976 (UMLS CUI [2,2])
C0003299 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C1565489 (UMLS CUI [2])
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])
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])
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])
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])
C0017125 (UMLS CUI [2])
C0017181 (UMLS CUI [2])
C0332185 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,2])
C0086287 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0038586 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,2])
C0560579 (UMLS CUI [2])
C1112219 (UMLS CUI [2])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
C0332185 (UMLS CUI [1,2])
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])