ID
42672
Descripción
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
Palabras clave
Versiones (3)
- 17/11/18 17/11/18 -
- 21/11/18 21/11/18 -
- 17/9/21 17/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
17 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
Eligibility Criteria
- StudyEvent: ODM
Descripción
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Descripción
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C1516637
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3898900
- UMLS CUI [2]
- C1519386
- UMLS CUI [3]
- C0001779
- UMLS CUI [4]
- C0079399
Descripción
Females of non-childbearing potential or of childbearing potential with negative pregnancy test and using certain contraceptive method(s)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
- UMLS CUI [3]
- C0427780
Descripción
Stable regimen of oral contraceptives
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0009905
- UMLS CUI [1,2]
- C0237125
- UMLS CUI [1,3]
- C0205360
Descripción
BMI: 20-32 kg/m2
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1305855
Descripción
QTc <450 msec or <480 msec if associated with bundle branch block
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0006384
Descripción
Willing and able to provide written informed consent
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0600109
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
Migraine attacks
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0149931
Descripción
Confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm
Tipo de datos
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
Descripción
Ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0034734
- UMLS CUI [2]
- C0085096
- UMLS CUI [3,1]
- C0022116
- UMLS CUI [3,2]
- C0000726
Descripción
Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating the study participation
Tipo de datos
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
Descripción
History of cerebrovascular pathology including stroke and/or transient ischemic attacks
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0007820
- UMLS CUI [2]
- C0559159
- UMLS CUI [3]
- C0007787
Descripción
Congenital heart disease
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0152021
Descripción
Hypertension at screening
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1868885
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C0428883
Descripción
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
Tipo de datos
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
Descripción
History of epilepsy or structural brain lesions lowering the convulsive threshold or recent treatment with an antiepileptic drug
Tipo de datos
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
Descripción
History of impaired hepatic or renal function
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0086565
- UMLS CUI [2]
- C1565489
Descripción
Herbal preparations containing St. John's Wort (Hypericum perforatum) currently or recently taken
Tipo de datos
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
Descripción
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, excluded acetaminophen at certain doses and contraceptives
Tipo de datos
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
Descripción
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.
Tipo de datos
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
Descripción
Gastrointestinal surgery due to bleeding, ulceration or perforation
Tipo de datos
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
Descripción
History of gastric bypass or stapling surgery
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0149701
- UMLS CUI [2]
- C0017125
Descripción
History of GI ulceration or gastrointestinal bleeding
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1963975
- UMLS CUI [2]
- C0017181
Descripción
History of inflammatory bowel disease
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021390
Descripción
Recent treatment with an investigational drug
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332185
Descripción
Positive serum beta-hCG test (females)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1255526
- UMLS CUI [1,2]
- C1446409
- UMLS CUI [1,3]
- C0086287
Descripción
Pregnant, actively trying to become pregnant or breast-feeding
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C0032992
Descripción
History of drug or alcohol abuse
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0038586
Descripción
Regular Alcohol consumption as measured by alcohol units/week
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0205272
- UMLS CUI [2]
- C0560579
Descripción
Positive urine drug screening including alcohol
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0743300
- UMLS CUI [2]
- C1112219
Descripción
Infection status of hepatitis B, hepatitis C and HIV
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
- UMLS CUI [3]
- C0019699
Descripción
Donation of blood
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005794
Descripción
Recent use of tobacco
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0332185
Descripción
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity the study medications or components
Tipo de datos
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])