ID
32376
Beschreibung
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
Stichworte
Versionen (4)
- 28.10.18 28.10.18 -
- 29.10.18 29.10.18 -
- 30.10.18 30.10.18 -
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
28. Oktober 2018
DOI
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Lizenz
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
Beschreibung
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
At least a 6 month history of migraine with or without aura
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3808875
Beschreibung
2-6 migraine attacks per month in the three months prior to screening
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1304680
- UMLS CUI [1,3]
- C0439507
Beschreibung
Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
Datentyp
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
Beschreibung
Ability to distinguish between mild migraine pain and other headache types
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C0205235
- UMLS CUI [1,3]
- C0149931
- UMLS CUI [1,4]
- C0018681
Beschreibung
Ability to read, comprehend and complete subject diaries; treatment of the migraine during the mild pain phase
Datentyp
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
Beschreibung
Ability and willingness to give written informed consent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [2,1]
- C0021430
- UMLS CUI [2,2]
- C0600109
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm
Datentyp
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
Beschreibung
Evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085096
- UMLS CUI [2]
- C0034734
- UMLS CUI [3,1]
- C0235490
- UMLS CUI [3,2]
- C0000726
Beschreibung
Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating a study participation
Datentyp
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
Beschreibung
Cerebrovascular pathology including stroke and/or transient ischemic attacks
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038454
- UMLS CUI [2]
- C0007787
Beschreibung
Congenital heart disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0152021
Beschreibung
Uncontrolled hypertension at screening
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1868885
- UMLS CUI [1,2]
- C1409616
Beschreibung
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)
Datentyp
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
Beschreibung
Epilepsy or structural brain lesions lowering the convulsive threshold or treatment with an antiepileptic drug within 5 years prior to screening
Datentyp
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
Beschreibung
Basilar or hemiplegic migraine
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0270860
- UMLS CUI [2]
- C0270862
Beschreibung
Impairment of hepatic or renal function contraindication a participation in this study
Datentyp
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
Beschreibung
Headache > 15 days/month recently
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0556971
- UMLS CUI [1,3]
- C0332185
Beschreibung
< 15 days/month of headache-free days recently
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0556971
- UMLS CUI [1,2]
- C0332288
- UMLS CUI [1,3]
- C0018681
- UMLS CUI [1,4]
- C0332185
Beschreibung
Current or recent treatment with a monoamine oxidase inhibitor
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0026457
- UMLS CUI [1,2]
- C2827774
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0026457
Beschreibung
Current or recent medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide
Datentyp
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
Beschreibung
Currently taking any anti-coagulant (e.g., Coumadin)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2827774
- UMLS CUI [1,2]
- C0003280
- UMLS CUI [2]
- C0699129
Beschreibung
Current or recent intake of herbal preparations containing St. John's Wort (Hypericum perforatum)
Datentyp
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
Beschreibung
Hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of its components or any other 5-HT1 receptor agonist.
Datentyp
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
Beschreibung
History of allergic reactions to naproxen preparations, including the syndrome of asthma, rhinitis, and nasal polyps due to aspirin or other NSAID drugs
Datentyp
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
Beschreibung
History of gastrointestinal surgery specifically indicating a past history of bleeding, ulceration or perforation
Datentyp
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
Beschreibung
History of gastric bypass or stapling surgery
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0017125
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0149701
- UMLS CUI [2,2]
- C0262926
Beschreibung
Recent history of GI ulceration or gastrointestinal bleeding
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0237938
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0017181
- UMLS CUI [2,2]
- C0332185
Beschreibung
History of inflammatory bowel disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021390
Beschreibung
History of any bleeding disorder
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005779
Beschreibung
Intake of any antiplatelet agent (except low-dose aspirin <325 mg/day for cardioprotective reasons)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085826
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C2608320
Beschreibung
Intake of any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0003015
- UMLS CUI [2]
- C0521942
Beschreibung
Pregnancy, actively trying to become pregnant or breast-feeding
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C0032992
Beschreibung
Evidence of alcohol or substance abuse within the last year which will likely interfere with the study
Datentyp
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
Beschreibung
Concurrent medical or psychiatric condition which may affect the study interpretation or otherwise contraindicates a participation
Datentyp
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
Beschreibung
Recent or planned participation in an investigational drug trial, excepting a previous study evaluating Trexima more than 7 days ago
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0332300
- UMLS CUI [1,4]
- C1724412
Ähnliche Modelle
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])