ID
32376
Description
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
Keywords
Versions (4)
- 10/28/18 10/28/18 -
- 10/29/18 10/29/18 -
- 10/30/18 10/30/18 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 28, 2018
DOI
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License
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
Description
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
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.
Data type
boolean
Alias
- UMLS CUI [1]
- C0079399
Description
At least a 6 month history of migraine with or without aura
Data type
boolean
Alias
- UMLS CUI [1]
- C3808875
Description
2-6 migraine attacks per month in the three months prior to screening
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1304680
- UMLS CUI [1,3]
- C0439507
Description
Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
Data type
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
Description
Ability to distinguish between mild migraine pain and other headache types
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C0205235
- UMLS CUI [1,3]
- C0149931
- UMLS CUI [1,4]
- C0018681
Description
Ability to read, comprehend and complete subject diaries; treatment of the migraine during the mild pain phase
Data type
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
Description
Ability and willingness to give written informed consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [2,1]
- C0021430
- UMLS CUI [2,2]
- C0600109
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
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]
- C0151744
- UMLS CUI [2]
- C0002962
- UMLS CUI [3]
- C0027051
- UMLS CUI [4]
- C0340291
- UMLS CUI [5]
- C0002963
- UMLS CUI [6]
- C0010073
Description
Evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome.
Data type
boolean
Alias
- UMLS CUI [1]
- C0085096
- UMLS CUI [2]
- C0034734
- UMLS CUI [3,1]
- C0235490
- UMLS CUI [3,2]
- C0000726
Description
Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating a study participation
Data type
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
Description
Cerebrovascular pathology including stroke and/or transient ischemic attacks
Data type
boolean
Alias
- UMLS CUI [1]
- C0038454
- UMLS CUI [2]
- C0007787
Description
Congenital heart disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0152021
Description
Uncontrolled hypertension at screening
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1868885
- UMLS CUI [1,2]
- C1409616
Description
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)
Data type
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
Description
Epilepsy or structural brain lesions lowering the convulsive threshold or treatment with an antiepileptic drug within 5 years prior to screening
Data type
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
Description
Basilar or hemiplegic migraine
Data type
boolean
Alias
- UMLS CUI [1]
- C0270860
- UMLS CUI [2]
- C0270862
Description
Impairment of hepatic or renal function contraindication a participation in this study
Data type
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
Description
Headache > 15 days/month recently
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0556971
- UMLS CUI [1,3]
- C0332185
Description
< 15 days/month of headache-free days recently
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0556971
- UMLS CUI [1,2]
- C0332288
- UMLS CUI [1,3]
- C0018681
- UMLS CUI [1,4]
- C0332185
Description
Current or recent treatment with a monoamine oxidase inhibitor
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0026457
- UMLS CUI [1,2]
- C2827774
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0026457
Description
Current or recent medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide
Data type
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
Description
Currently taking any anti-coagulant (e.g., Coumadin)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2827774
- UMLS CUI [1,2]
- C0003280
- UMLS CUI [2]
- C0699129
Description
Current or recent intake of herbal preparations containing St. John's Wort (Hypericum perforatum)
Data type
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
Description
Hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of its components 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]
- 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
Description
History of allergic reactions to naproxen preparations, including the syndrome of asthma, rhinitis, and nasal polyps due to aspirin or other NSAID drugs
Data type
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
Description
History of gastrointestinal surgery specifically indicating a past history of bleeding, ulceration or perforation
Data type
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
Description
History of gastric bypass or stapling surgery
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0017125
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0149701
- UMLS CUI [2,2]
- C0262926
Description
Recent history of GI ulceration or gastrointestinal bleeding
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0237938
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0017181
- UMLS CUI [2,2]
- C0332185
Description
History of inflammatory bowel disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0021390
Description
History of any bleeding disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0005779
Description
Intake of any antiplatelet agent (except low-dose aspirin <325 mg/day for cardioprotective reasons)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085826
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C2608320
Description
Intake of any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker
Data type
boolean
Alias
- UMLS CUI [1]
- C0003015
- UMLS CUI [2]
- C0521942
Description
Pregnancy, 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
Evidence of alcohol or substance abuse within the last year which will likely interfere with the study
Data type
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
Description
Concurrent medical or psychiatric condition which may affect the study interpretation or otherwise contraindicates a participation
Data type
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
Description
Recent or planned participation in an investigational drug trial, excepting a previous study evaluating Trexima more than 7 days ago
Data type
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])