ID
30765
Beskrivning
https://www.gsk-clinicalstudyregister.com/study/101998#rs Study ID:101998 Clinical Study ID :101998 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 Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders
Länk
https://www.gsk-clinicalstudyregister.com/study/101998#rs
Nyckelord
Versioner (6)
- 2018-06-20 2018-06-20 - Halim Ugurlu
- 2019-01-11 2019-01-11 -
- 2019-01-13 2019-01-13 -
- 2019-01-18 2019-01-18 -
- 2019-01-18 2019-01-18 - Sarah Riepenhausen
- 2021-09-20 2021-09-20 -
Rättsinnehavare
GlaxoSmithKline (GSK)
Uppladdad den
20 juni 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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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
Case Report Form-Module Number 1a (DEMOGRAPHY, CHILD-BEARING POTENTIAL, BIRTH CONTROL METHODS, MEDICAL CONDITIONS, ELIGIBILITY CRITERIA)
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Sex
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Ethnicity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
Race
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Child-Bearing Potential (Complete for Female Subjects Only)
Alias
- UMLS CUI-1
- C3831118
Beskrivning
Birth Control Methods
Alias
- UMLS CUI-1
- C0700589
Beskrivning
Oral contraceptive
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009905
Beskrivning
Intrauterine contraceptive device
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021900
- UMLS CUI [1,2]
- C0700589
Beskrivning
Depot contraceptive (implants, injectables)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0086129
Beskrivning
Spermicide plus physical barrier
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0004764
- UMLS CUI [1,2]
- C0087145
Beskrivning
*Barrier method only if used in combination with any of the other acceptable contraception methods.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0042241
- UMLS CUI [1,2]
- C3873750
Beskrivning
Abstinence
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3843422
Beskrivning
Sterilization of male partner
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0024559
Beskrivning
Other, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Beskrivning
Medical Conditions
Alias
- UMLS CUI-1
- C0205476
- UMLS CUI-2
- C0348080
Beskrivning
Blood and lymphatic system disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0851353
Beskrivning
Cardiac disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0018799
Beskrivning
Ear and labyrinth disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0851354
Beskrivning
Endocrine disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0014130
Beskrivning
Eye disorders
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
Beskrivning
Gastrointestinal disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0017178
Beskrivning
Hepatobiliary disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0267792
Beskrivning
Immune system disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C1334156
Beskrivning
Metabolism and nutrition disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0851358
Beskrivning
Musculoskeletal and connective tissue disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0263660
Beskrivning
Nervous system disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0027765
Beskrivning
Psychiatric disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0004936
Beskrivning
Renal and urinary disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0042075
Beskrivning
Reproductive system and breast disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0851366
Beskrivning
Respiratory, thoracic and mediastinal disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0851355
Beskrivning
Skin and subcutaneous tissue disorders
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037274
- UMLS CUI [1,2]
- C0178301
Beskrivning
Vascular disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0042373
Beskrivning
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C1516637
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
text
Alias
- UMLS CUI [1]
- C0150831
Beskrivning
At least a 6 month history of migraine with aura or migraine without aura
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0154723
- UMLS CUI [2]
- C1389175
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
Moderate to severe migraine pain
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2957106
- UMLS CUI [1,2]
- C0149931
Beskrivning
Able to distinguish between mild migraine pain and other headache types
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0162340
- UMLS CUI [1,2]
- C0278138
- UMLS CUI [1,3]
- C0149931
- UMLS CUI [1,4]
- C0018681
- UMLS CUI [1,5]
- C0205394
Beskrivning
Able to read, comprehend and complete subject diaries
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0586740
- UMLS CUI [1,2]
- C0162340
- UMLS CUI [1,3]
- C0584993
- UMLS CUI [1,4]
- C1321605
Beskrivning
Able and willing to give written informed consent to participate in the study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
ischemic heart disease, Prinzmetal ’ s angina/coronary vasospasm, or signs/symptoms consistent with any of the above
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0010068
- UMLS CUI [1,2]
- C0151744
- UMLS CUI [1,3]
- C0085616
- UMLS CUI [1,4]
- C0002963
Beskrivning
Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud ’ s Syndrome
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0034734
- UMLS CUI [1,2]
- C0007787
- UMLS CUI [1,3]
- C1881056
Beskrivning
cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2985739
Beskrivning
history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0007787
Beskrivning
history of congenital heart disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0152021
- UMLS CUI [1,2]
- C0262926
Beskrivning
uncontrolled hypertension
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1868885
Beskrivning
unrecognized cardiovascular or cerebrovascular disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0007222
- UMLS CUI [2,1]
- C0038454
- UMLS CUI [2,2]
- C4288068
Beskrivning
history of epilepsy or structural brain lesions
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0014544
- UMLS CUI [2]
- C0851391
Beskrivning
Subject has basilar (ICHD-II 1.2.6) or hemiplegic (ICHD-II 1.2.4) migraine.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0270860
- UMLS CUI [2]
- C0270862
Beskrivning
impaired hepatic or renal function
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0086565
- UMLS CUI [2]
- C1565489
Beskrivning
Subject has had headache > 15 days/month in either of the three months prior to screening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0556971
Beskrivning
Subject has < 15 days/month of headache-free days in either of the three months prior to screening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3843208
- UMLS CUI [1,2]
- C0556971
Beskrivning
monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0026457
Beskrivning
migraine prophylactic medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0420172
- UMLS CUI [1,2]
- C0025842
- UMLS CUI [1,3]
- C0012291
- UMLS CUI [1,4]
- C0014710
Beskrivning
Subject is currently taking any anti-coagulant (e.g., Coumadin).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0699129
- UMLS CUI [1,2]
- C0003280
Beskrivning
herbal preparations containing St. John ’ s Wort
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0936242
- UMLS CUI [1,2]
- C0332256
- UMLS CUI [1,3]
- C0013227
Beskrivning
hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0337443
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C1301624
- UMLS CUI [1,4]
- C0075632
- UMLS CUI [1,5]
- C0027396
Beskrivning
history of allergic reactions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C2106654
- UMLS CUI [1,3]
- C0004057
- UMLS CUI [1,4]
- C0027396
- UMLS CUI [1,5]
- C0003211
Beskrivning
history of any gastrointestinal surgery
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0524722
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1963975
- UMLS CUI [1,4]
- C0017181
- UMLS CUI [1,5]
- C0151664
- UMLS CUI [1,6]
- C0262926
Beskrivning
Subject has a history of gastric bypass or stapling surgery
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0017125
- UMLS CUI [1,2]
- C0543467
Beskrivning
GI ulceration in the past six months or gastrointestinal bleeding in the past year
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0237938
- UMLS CUI [1,2]
- C4086728
- UMLS CUI [2,1]
- C0017181
- UMLS CUI [2,2]
- C3828652
Beskrivning
Subject has a history of inflammatory bowel disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021390
Beskrivning
Subject has a history of any bleeding disorder
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005779
Beskrivning
antiplatelet agent
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1096021
- UMLS CUI [1,2]
- C0332300
- UMLS CUI [1,3]
- C0004057
- UMLS CUI [1,4]
- C0445550
Beskrivning
Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0003015
- UMLS CUI [1,2]
- C0521942
Beskrivning
Subject is pregnant, actively trying to become pregnant or breast-feeding
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beskrivning
alcohol or substance abuse
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085762
- UMLS CUI [1,2]
- C0038586
Beskrivning
concurrent medical or psychiatric condition
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0004936
Beskrivning
Investigational drug trial within the previous four weeks
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
Similar models
Case Report Form-Module Number 1a (DEMOGRAPHY, CHILD-BEARING POTENTIAL, BIRTH CONTROL METHODS, MEDICAL CONDITIONS, ELIGIBILITY CRITERIA)
C0019994 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
C0086129 (UMLS CUI [1,2])
C0087145 (UMLS CUI [1,2])
C3873750 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0178301 (UMLS CUI [1,2])
C1389175 (UMLS CUI [2])
C1304680 (UMLS CUI [1,2])
C0439507 (UMLS CUI [1,3])
C0149931 (UMLS CUI [1,2])
C0278138 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C0162340 (UMLS CUI [1,2])
C0584993 (UMLS CUI [1,3])
C1321605 (UMLS CUI [1,4])
C0151744 (UMLS CUI [1,2])
C0085616 (UMLS CUI [1,3])
C0002963 (UMLS CUI [1,4])
C0007787 (UMLS CUI [1,2])
C1881056 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,2])
C0007787 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2,1])
C4288068 (UMLS CUI [2,2])
C0851391 (UMLS CUI [2])
C0270862 (UMLS CUI [2])
C1565489 (UMLS CUI [2])
C0556971 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,2])
C0026457 (UMLS CUI [1,2])
C0025842 (UMLS CUI [1,2])
C0012291 (UMLS CUI [1,3])
C0014710 (UMLS CUI [1,4])
C0003280 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0020517 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0075632 (UMLS CUI [1,4])
C0027396 (UMLS CUI [1,5])
C2106654 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0027396 (UMLS CUI [1,4])
C0003211 (UMLS CUI [1,5])
C3146298 (UMLS CUI [1,2])
C1963975 (UMLS CUI [1,3])
C0017181 (UMLS CUI [1,4])
C0151664 (UMLS CUI [1,5])
C0262926 (UMLS CUI [1,6])
C0543467 (UMLS CUI [1,2])
C4086728 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2,1])
C3828652 (UMLS CUI [2,2])
C0332300 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0445550 (UMLS CUI [1,4])
C0521942 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
C0038586 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])