ID
42672
Beskrivning
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).
Länk
https://clinicaltrials.gov/ct2/show/NCT00875784
Nyckelord
Versioner (3)
- 2018-11-17 2018-11-17 -
- 2018-11-21 2018-11-21 -
- 2021-09-17 2021-09-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
17 september 2021
DOI
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Licens
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
Eligibility Criteria
- StudyEvent: ODM
Beskrivning
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C1516637
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3898900
- UMLS CUI [2]
- C1519386
- UMLS CUI [3]
- C0001779
- UMLS CUI [4]
- C0079399
Beskrivning
Females of non-childbearing potential or of childbearing potential with negative pregnancy test and using certain contraceptive method(s)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
- UMLS CUI [3]
- C0427780
Beskrivning
Stable regimen of oral contraceptives
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009905
- UMLS CUI [1,2]
- C0237125
- UMLS CUI [1,3]
- C0205360
Beskrivning
BMI: 20-32 kg/m2
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1305855
Beskrivning
QTc <450 msec or <480 msec if associated with bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0006384
Beskrivning
Willing and able to provide written informed consent
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0600109
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Migraine attacks
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0149931
Beskrivning
Confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm
Datatyp
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
Beskrivning
Ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0034734
- UMLS CUI [2]
- C0085096
- UMLS CUI [3,1]
- C0022116
- UMLS CUI [3,2]
- C0000726
Beskrivning
Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating the study participation
Datatyp
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
Beskrivning
History of cerebrovascular pathology including stroke and/or transient ischemic attacks
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0007820
- UMLS CUI [2]
- C0559159
- UMLS CUI [3]
- C0007787
Beskrivning
Congenital heart disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0152021
Beskrivning
Hypertension at screening
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1868885
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C0428883
Beskrivning
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
Datatyp
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
Beskrivning
History of epilepsy or structural brain lesions lowering the convulsive threshold or recent treatment with an antiepileptic drug
Datatyp
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
Beskrivning
History of impaired hepatic or renal function
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0086565
- UMLS CUI [2]
- C1565489
Beskrivning
Herbal preparations containing St. John's Wort (Hypericum perforatum) currently or recently taken
Datatyp
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
Beskrivning
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, excluded acetaminophen at certain doses and contraceptives
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
Gastrointestinal surgery due to bleeding, ulceration or perforation
Datatyp
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
Beskrivning
History of gastric bypass or stapling surgery
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0149701
- UMLS CUI [2]
- C0017125
Beskrivning
History of GI ulceration or gastrointestinal bleeding
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1963975
- UMLS CUI [2]
- C0017181
Beskrivning
History of inflammatory bowel disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021390
Beskrivning
Recent treatment with an investigational drug
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332185
Beskrivning
Positive serum beta-hCG test (females)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1255526
- UMLS CUI [1,2]
- C1446409
- UMLS CUI [1,3]
- C0086287
Beskrivning
Pregnant, actively trying to become pregnant or breast-feeding
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C0032992
Beskrivning
History of drug or alcohol abuse
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0038586
Beskrivning
Regular Alcohol consumption as measured by alcohol units/week
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0205272
- UMLS CUI [2]
- C0560579
Beskrivning
Positive urine drug screening including alcohol
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0743300
- UMLS CUI [2]
- C1112219
Beskrivning
Infection status of hepatitis B, hepatitis C and HIV
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
- UMLS CUI [3]
- C0019699
Beskrivning
Donation of blood
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005794
Beskrivning
Recent use of tobacco
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0332185
Beskrivning
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity the study medications or components
Datatyp
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])