ID
32376
Beskrivning
This ODM-file contains the eligibility criteria. To be assessed at screening. Study ID: 101199 Clinical Study ID: 101199 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders
Nyckelord
Versioner (4)
- 2018-10-28 2018-10-28 -
- 2018-10-29 2018-10-29 -
- 2018-10-30 2018-10-30 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
28 oktober 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101199
Eligibility Criteria
- StudyEvent: ODM
Beskrivning
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
Age
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
A female is eligible to enter and participate in this study if she is of: a) non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b) child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and agrees to one of the following: • Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval (5 days) after completion or premature discontinuation from the study to account for elimination of the investigational drug; subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent when they present to the clinic for the Final Visit 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 1% per year (not all IUDs meet this criterion); or, • Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm) • Any other Barrier method (only if used in combination with any of the above acceptable methods) or, • Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
At least a 6 month history of migraine with or without aura
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3808875
Beskrivning
2-6 migraine attacks per month in the three months prior to screening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1304680
- UMLS CUI [1,3]
- C0439507
Beskrivning
Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1320357
- UMLS CUI [2,1]
- C0149931
- UMLS CUI [2,2]
- C0278138
- UMLS CUI [2,3]
- C0205390
Beskrivning
Ability to distinguish between mild migraine pain and other headache types
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C0205235
- UMLS CUI [1,3]
- C0149931
- UMLS CUI [1,4]
- C0018681
Beskrivning
Ability to read, comprehend and complete subject diaries; treatment of the migraine during the mild pain phase
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0586740
- UMLS CUI [2,1]
- C0162340
- UMLS CUI [2,2]
- C1321605
- UMLS CUI [3,1]
- C0087111
- UMLS CUI [3,2]
- C0149931
- UMLS CUI [3,3]
- C0347984
- UMLS CUI [3,4]
- C0278138
Beskrivning
Ability and willingness to give written informed consent
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [2,1]
- C0021430
- UMLS CUI [2,2]
- C0600109
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
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]
- C0151744
- UMLS CUI [2]
- C0002962
- UMLS CUI [3]
- C0027051
- UMLS CUI [4]
- C0340291
- UMLS CUI [5]
- C0002963
- UMLS CUI [6]
- C0010073
Beskrivning
Evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085096
- UMLS CUI [2]
- C0034734
- UMLS CUI [3,1]
- C0235490
- UMLS CUI [3,2]
- C0000726
Beskrivning
Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating a study participation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0003811
- UMLS CUI [1,2]
- C0332121
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [2,1]
- C1832603
- UMLS CUI [2,2]
- C2985739
- UMLS CUI [2,3]
- C0522473
- UMLS CUI [2,4]
- C2348568
Beskrivning
Cerebrovascular pathology including stroke and/or transient ischemic attacks
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038454
- UMLS CUI [2]
- C0007787
Beskrivning
Congenital heart disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0152021
Beskrivning
Uncontrolled hypertension at screening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1868885
- UMLS CUI [1,2]
- C1409616
Beskrivning
Likely to have unrecognized cardiovascular or cerebrovascular disease (e.g. hypertension, hypercholesterolemia, smoker, 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]
- C4288068
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [2,1]
- C4288068
- UMLS CUI [2,2]
- C0007820
- UMLS CUI [3]
- C0020538
- UMLS CUI [4]
- C0020443
- UMLS CUI [5]
- C0337664
- UMLS CUI [6]
- C0028754
- UMLS CUI [7]
- C0011849
- UMLS CUI [8]
- C2317524
- UMLS CUI [9]
- C0025320
- UMLS CUI [10,1]
- C0024554
- UMLS CUI [10,2]
- C0001779
Beskrivning
Epilepsy or structural brain lesions lowering the convulsive threshold or treatment with an antiepileptic drug within 5 years prior to screening
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0014544
- UMLS CUI [2,1]
- C0221505
- UMLS CUI [2,2]
- C0234976
- UMLS CUI [3,1]
- C0003299
- UMLS CUI [3,2]
- C0332185
Beskrivning
Basilar or hemiplegic migraine
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0270860
- UMLS CUI [2]
- C0270862
Beskrivning
Impairment of hepatic or renal function contraindication a participation in this study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0948807
- UMLS CUI [1,2]
- C0522473
- UMLS CUI [1,3]
- C2348568
- UMLS CUI [2,1]
- C1565489
- UMLS CUI [2,2]
- C0522473
- UMLS CUI [2,3]
- C2348568
Beskrivning
Headache > 15 days/month recently
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0556971
- UMLS CUI [1,3]
- C0332185
Beskrivning
< 15 days/month of headache-free days recently
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0556971
- UMLS CUI [1,2]
- C0332288
- UMLS CUI [1,3]
- C0018681
- UMLS CUI [1,4]
- C0332185
Beskrivning
Current or recent treatment with a monoamine oxidase inhibitor
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0026457
- UMLS CUI [1,2]
- C2827774
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0026457
Beskrivning
Current or recent medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2827774
- UMLS CUI [1,2]
- C0012291
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0012291
- UMLS CUI [3,1]
- C2827774
- UMLS CUI [3,2]
- C0014710
- UMLS CUI [4,1]
- C0332185
- UMLS CUI [4,2]
- C0014710
- UMLS CUI [5,1]
- C2827774
- UMLS CUI [5,2]
- C0025842
- UMLS CUI [6,1]
- C0332185
- UMLS CUI [6,2]
- C0025842
Beskrivning
Currently taking any anti-coagulant (e.g., Coumadin)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2827774
- UMLS CUI [1,2]
- C0003280
- UMLS CUI [2]
- C0699129
Beskrivning
Current or recent intake of herbal preparations containing St. John's Wort (Hypericum perforatum)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C1360419
- UMLS CUI [1,3]
- C0936242
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C1360419
- UMLS CUI [2,3]
- C0936242
Beskrivning
Hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of its components 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]
- C0546873
- UMLS CUI [5,1]
- C0277585
- UMLS CUI [5,2]
- C0546873
- UMLS CUI [6,1]
- C1301624
- UMLS CUI [6,2]
- C0546873
- UMLS CUI [7,1]
- C0020517
- UMLS CUI [7,2]
- C0162754
- UMLS CUI [8,1]
- C0277585
- UMLS CUI [8,2]
- C0162754
- UMLS CUI [9,1]
- C1301624
- UMLS CUI [9,2]
- C0162754
Beskrivning
History of allergic reactions to naproxen preparations, including the syndrome of asthma, rhinitis, and nasal polyps due to aspirin or other NSAID drugs
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1527304
- UMLS CUI [1,2]
- C0027396
- UMLS CUI [2,1]
- C0003211
- UMLS CUI [2,2]
- C0004096
- UMLS CUI [2,3]
- C0035455
- UMLS CUI [2,4]
- C0027430
- UMLS CUI [3,1]
- C0004057
- UMLS CUI [3,2]
- C0004096
- UMLS CUI [3,3]
- C0035455
- UMLS CUI [3,4]
- C0027430
Beskrivning
History of gastrointestinal surgery specifically indicating a past history of bleeding, ulceration or perforation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0524722
- UMLS CUI [1,3]
- C1963975
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0524722
- UMLS CUI [2,3]
- C0017181
- UMLS CUI [3,1]
- C0262926
- UMLS CUI [3,2]
- C0524722
- UMLS CUI [3,3]
- C0151664
Beskrivning
History of gastric bypass or stapling surgery
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0017125
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0149701
- UMLS CUI [2,2]
- C0262926
Beskrivning
Recent history of GI ulceration or gastrointestinal bleeding
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0237938
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0017181
- UMLS CUI [2,2]
- C0332185
Beskrivning
History of inflammatory bowel disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021390
Beskrivning
History of any bleeding disorder
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005779
Beskrivning
Intake of any antiplatelet agent (except low-dose aspirin <325 mg/day for cardioprotective reasons)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085826
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C2608320
Beskrivning
Intake of any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0003015
- UMLS CUI [2]
- C0521942
Beskrivning
Pregnancy, actively trying to become pregnant or breast-feeding
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C0032992
Beskrivning
Evidence of alcohol or substance abuse within the last year which will likely interfere with the study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085762
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C2603343
- UMLS CUI [2,1]
- C0038586
- UMLS CUI [2,2]
- C0521102
- UMLS CUI [2,3]
- C2603343
Beskrivning
Concurrent medical or psychiatric condition which may affect the study interpretation or otherwise contraindicates a participation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C1264692
- UMLS CUI [2,1]
- C0004936
- UMLS CUI [2,2]
- C0521102
- UMLS CUI [2,3]
- C1264692
- UMLS CUI [3,1]
- C1301624
- UMLS CUI [3,2]
- C2348568
Beskrivning
Recent or planned participation in an investigational drug trial, excepting a previous study evaluating Trexima more than 7 days ago
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0332300
- UMLS CUI [1,4]
- C1724412
Similar models
Eligibility Criteria
- StudyEvent: ODM
C1304680 (UMLS CUI [1,2])
C0439507 (UMLS CUI [1,3])
C1320357 (UMLS CUI [1,2])
C0149931 (UMLS CUI [2,1])
C0278138 (UMLS CUI [2,2])
C0205390 (UMLS CUI [2,3])
C0205235 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,4])
C0162340 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0149931 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C0278138 (UMLS CUI [3,4])
C0085732 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
C0002963 (UMLS CUI [5])
C0010073 (UMLS CUI [6])
C0034734 (UMLS CUI [2])
C0235490 (UMLS CUI [3,1])
C0000726 (UMLS CUI [3,2])
C0332121 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1832603 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C0522473 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0007787 (UMLS CUI [2])
C1409616 (UMLS CUI [1,2])
C0007222 (UMLS CUI [1,2])
C4288068 (UMLS CUI [2,1])
C0007820 (UMLS CUI [2,2])
C0020538 (UMLS CUI [3])
C0020443 (UMLS CUI [4])
C0337664 (UMLS CUI [5])
C0028754 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
C2317524 (UMLS CUI [8])
C0025320 (UMLS CUI [9])
C0024554 (UMLS CUI [10,1])
C0001779 (UMLS CUI [10,2])
C0221505 (UMLS CUI [2,1])
C0234976 (UMLS CUI [2,2])
C0003299 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0270862 (UMLS CUI [2])
C0522473 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1565489 (UMLS CUI [2,1])
C0522473 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0556971 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0332288 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
C2827774 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0026457 (UMLS CUI [2,2])
C0012291 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0012291 (UMLS CUI [2,2])
C2827774 (UMLS CUI [3,1])
C0014710 (UMLS CUI [3,2])
C0332185 (UMLS CUI [4,1])
C0014710 (UMLS CUI [4,2])
C2827774 (UMLS CUI [5,1])
C0025842 (UMLS CUI [5,2])
C0332185 (UMLS CUI [6,1])
C0025842 (UMLS CUI [6,2])
C0003280 (UMLS CUI [1,2])
C0699129 (UMLS CUI [2])
C1360419 (UMLS CUI [1,2])
C0936242 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C1360419 (UMLS CUI [2,2])
C0936242 (UMLS CUI [2,3])
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])
C0546873 (UMLS CUI [4,2])
C0277585 (UMLS CUI [5,1])
C0546873 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0546873 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0162754 (UMLS CUI [7,2])
C0277585 (UMLS CUI [8,1])
C0162754 (UMLS CUI [8,2])
C1301624 (UMLS CUI [9,1])
C0162754 (UMLS CUI [9,2])
C0027396 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0035455 (UMLS CUI [2,3])
C0027430 (UMLS CUI [2,4])
C0004057 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C0035455 (UMLS CUI [3,3])
C0027430 (UMLS CUI [3,4])
C0524722 (UMLS CUI [1,2])
C1963975 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0524722 (UMLS CUI [2,2])
C0017181 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0524722 (UMLS CUI [3,2])
C0151664 (UMLS CUI [3,3])
C0262926 (UMLS CUI [1,2])
C0149701 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0332185 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1705847 (UMLS CUI [1,2])
C2608320 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0521102 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2603343 (UMLS CUI [2,3])
C0521102 (UMLS CUI [1,2])
C1264692 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1264692 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0013230 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C1724412 (UMLS CUI [1,4])