ID
32872
Beschrijving
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
Trefwoorden
Versies (3)
- 17-11-18 17-11-18 -
- 21-11-18 21-11-18 -
- 17-09-21 17-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
17 november 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Eligibility Criteria
- StudyEvent: ODM
Beschrijving
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C1516637
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C3898900
- UMLS CUI [2]
- C1519386
- UMLS CUI [3,1]
- C0001675
- UMLS CUI [3,2]
- C0001779
- UMLS CUI [4]
- C0079399
Beschrijving
Females of non-childbearing potential or of childbearing potential with negative pregnancy test and using certain contraceptive method(s)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0086287
- UMLS CUI [1,2]
- C3831118
- UMLS CUI [1,3]
- C0700589
Beschrijving
Stable regimen of oral contraceptives
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009905
- UMLS CUI [1,2]
- C0237125
- UMLS CUI [1,3]
- C0205360
Beschrijving
BMI: 20-32 kg/m2
Datatype
boolean
Alias
- UMLS CUI [1]
- C1305855
Beschrijving
QTc <450 msec or <480 msec if associated with bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0006384
Beschrijving
Willing and able to provide written informed consent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0600109
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Migraine attacks
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149931
Beschrijving
Confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm
Datatype
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
Beschrijving
Ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034734
- UMLS CUI [2]
- C0085096
- UMLS CUI [3,1]
- C0022116
- UMLS CUI [3,2]
- C0000726
Beschrijving
Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating the study participation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0003811
- UMLS CUI [1,2]
- C1514873
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [2,1]
- C1832603
- UMLS CUI [2,2]
- C2985739
- UMLS CUI [2,3]
- C1301624
- UMLS CUI [2,4]
- C2348568
Beschrijving
History of cerebrovascular pathology including stroke and/or transient ischemic attacks
Datatype
boolean
Alias
- UMLS CUI [1]
- C0007820
- UMLS CUI [2]
- C0559159
Beschrijving
Congenital heart disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0152021
Beschrijving
Hypertension at screening
Datatype
boolean
Alias
- UMLS CUI [1]
- C1868885
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C0428883
Beschrijving
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
Datatype
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
Beschrijving
History of epilepsy or structural brain lesions lowering the convulsive threshold or recent treatment with an antiepileptic drug
Datatype
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
Beschrijving
History of impaired hepatic or renal function
Datatype
boolean
Alias
- UMLS CUI [1]
- C0086565
- UMLS CUI [2]
- C1565489
Beschrijving
Herbal preparations containing St. John's Wort (Hypericum perforatum) currently or recently taken
Datatype
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
Beschrijving
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, excluded acetaminophen at certain doses and contraceptives
Datatype
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
Beschrijving
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.
Datatype
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
Beschrijving
Gastrointestinal surgery due to bleeding, ulceration or perforation
Datatype
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
Beschrijving
History of gastric bypass or stapling surgery
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149701
- UMLS CUI [2]
- C0017125
Beschrijving
History of GI ulceration or gastrointestinal bleeding
Datatype
boolean
Alias
- UMLS CUI [1]
- C1963975
- UMLS CUI [2]
- C0017181
Beschrijving
History of inflammatory bowel disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021390
Beschrijving
Recent treatment with an investigational drug
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332185
Beschrijving
Positive serum beta-hCG test (females)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1255526
- UMLS CUI [1,2]
- C1446409
- UMLS CUI [1,3]
- C0086287
Beschrijving
Pregnant, actively trying to become pregnant or breast-feeding
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C0032992
Beschrijving
History of drug or alcohol abuse
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0038586
Beschrijving
Regular Alcohol consumption as measured by alcohol units/week
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0205272
- UMLS CUI [1,3]
- C0560579
Beschrijving
Positive urine drug screening including alcohol
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0743300
- UMLS CUI [1,2]
- C0332257
- UMLS CUI [1,3]
- C1112219
Beschrijving
Infection status of hepatitis B, hepatitis C and HIV
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
- UMLS CUI [3]
- C0019699
Beschrijving
Donation of blood
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005794
Beschrijving
Recent use of tobacco
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0332185
Beschrijving
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity the study medications or components
Datatype
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])
C0001675 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
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])
C1832603 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C1301624 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0559159 (UMLS CUI [2])
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 [1,3])
C0332257 (UMLS CUI [1,2])
C1112219 (UMLS CUI [1,3])
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])