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ID
30765
Description
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
Link
https://www.gsk-clinicalstudyregister.com/study/101998#rs
Keywords
Versions (6)
- 20/06/2018 20/06/2018 - Halim Ugurlu
- 11/01/2019 11/01/2019 -
- 13/01/2019 13/01/2019 -
- 18/01/2019 18/01/2019 -
- 18/01/2019 18/01/2019 - Sarah Riepenhausen
- 20/09/2021 20/09/2021 -
Copyright Holder
GlaxoSmithKline (GSK)
Uploaded on
20 de junho de 2018
DOI
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License
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)
Similar models
Case Report Form-Module Number 1a (DEMOGRAPHY, CHILD-BEARING POTENTIAL, BIRTH CONTROL METHODS, MEDICAL CONDITIONS, ELIGIBILITY CRITERIA)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Child-Bearing Potential (Complete for Female Subjects Only)
C3831118 (UMLS CUI-1)
Item
Child-Bearing Potential (Complete for Female Subjects Only)
integer
C3831118 (UMLS CUI [1])
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Oral contraceptive
Item
Oral contraceptive
boolean
C0009905 (UMLS CUI [1])
Intrauterine contraceptive device
Item
Intrauterine contraceptive device
boolean
C0021900 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
Depot contraceptive (implants, injectables)
Item
Depot contraceptive (implants, injectables)
boolean
C0700589 (UMLS CUI [1,1])
C0086129 (UMLS CUI [1,2])
C0086129 (UMLS CUI [1,2])
Spermicide plus physical barrier
Item
Spermicide plus physical barrier
boolean
C0004764 (UMLS CUI [1,1])
C0087145 (UMLS CUI [1,2])
C0087145 (UMLS CUI [1,2])
Physical Barrier (condom, diaphragm)
Item
Physical Barrier* (condom, diaphragm)
boolean
C0042241 (UMLS CUI [1,1])
C3873750 (UMLS CUI [1,2])
C3873750 (UMLS CUI [1,2])
Abstinence
Item
Abstinence
boolean
C3843422 (UMLS CUI [1])
Sterilization of male partner
Item
Sterilization of male partner
boolean
C0024559 (UMLS CUI [1])
Other, specify
Item
Other, specify
text
C0700589 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item
Blood and lymphatic system disorders
text
C0851353 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
Item
Metabolism and nutrition disorders
text
C0851358 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
Item
Musculoskeletal and connective tissue disorders
text
C0263660 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
Item
Reproductive system and breast disorders
text
C0851366 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
Item
Respiratory, thoracic and mediastinal disorders
text
C0851355 (UMLS CUI [1])
Code List
Respiratory, thoracic and mediastinal disorders
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
Item
Skin and subcutaneous tissue disorders
text
C0037274 (UMLS CUI [1,1])
C0178301 (UMLS CUI [1,2])
C0178301 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
No Medical condition (5)
CL Item
Not Assessed (4)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Age
Item
Subject is at least 18 years, but not more than 65 years of age at the screening visit.
boolean
C0001779 (UMLS CUI [1])
Sex
Item
Subject is male or female
text
C0150831 (UMLS CUI [1])
At least a 6 month history of migraine with aura or migraine without aura
Item
Subject has at least a 6 month history that meets 2004 IHS Criteria for migraine with aura (ICHD-II 1.2.1) or migraine without aura (ICHD-II 1.1)
boolean
C0154723 (UMLS CUI [1])
C1389175 (UMLS CUI [2])
C1389175 (UMLS CUI [2])
2-6 migraine attacks per month in the three months prior to screening
Item
Subject has experienced 2-6 migraine attacks per month in the three months prior to screening
boolean
C0149931 (UMLS CUI [1,1])
C1304680 (UMLS CUI [1,2])
C0439507 (UMLS CUI [1,3])
C1304680 (UMLS CUI [1,2])
C0439507 (UMLS CUI [1,3])
Moderate to severe migraine pain
Item
Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
boolean
C2957106 (UMLS CUI [1,1])
C0149931 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,2])
Able to distinguish between mild migraine pain and other headache types
Item
Subject is able to distinguish between mild migraine pain and other headache types
boolean
C0162340 (UMLS CUI [1,1])
C0278138 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C0278138 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Able to read, comprehend and complete subject diaries
Item
Subject is able to read, comprehend and complete subject diaries and understand that they must treat their migraine during the mild pain phase.
boolean
C0586740 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C0584993 (UMLS CUI [1,3])
C1321605 (UMLS CUI [1,4])
C0162340 (UMLS CUI [1,2])
C0584993 (UMLS CUI [1,3])
C1321605 (UMLS CUI [1,4])
Able and willing to give written informed consent to participate in the study
Item
Subject is able and willing to give written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
ischemic heart disease, Prinzmetal ’ s angina/coronary vasospasm, or signs/symptoms consistent with any of the above
Item
Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal ’ s angina/coronary vasospasm, or signs/symptoms consistent with any of the above.
boolean
C0010068 (UMLS CUI [1,1])
C0151744 (UMLS CUI [1,2])
C0085616 (UMLS CUI [1,3])
C0002963 (UMLS CUI [1,4])
C0151744 (UMLS CUI [1,2])
C0085616 (UMLS CUI [1,3])
C0002963 (UMLS CUI [1,4])
Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud ’ s Syndrome
Item
Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud ’ s Syndrome
boolean
C0034734 (UMLS CUI [1,1])
C0007787 (UMLS CUI [1,2])
C1881056 (UMLS CUI [1,3])
C0007787 (UMLS CUI [1,2])
C1881056 (UMLS CUI [1,3])
cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality
Item
Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator ’ s opinion, contraindicates participation in this study.
boolean
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs)
Item
Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).
boolean
C0038454 (UMLS CUI [1,1])
C0007787 (UMLS CUI [1,2])
C0007787 (UMLS CUI [1,2])
history of congenital heart disease
Item
Subject has a history of congenital heart disease.
boolean
C0152021 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
uncontrolled hypertension
Item
Subject has uncontrolled hypertension at screening (sitting systolic pressure > 160mmHg, diastolic pressure > 95mmHg).
boolean
C1868885 (UMLS CUI [1])
unrecognized cardiovascular or cerebrovascular disease
Item
Subject, in the investigator ’ s opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (including but is not limited to, 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)
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2,1])
C4288068 (UMLS CUI [2,2])
C0038454 (UMLS CUI [2,1])
C4288068 (UMLS CUI [2,2])
history of epilepsy or structural brain lesions
Item
Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening
boolean
C0014544 (UMLS CUI [1])
C0851391 (UMLS CUI [2])
C0851391 (UMLS CUI [2])
Subject has basilar (ICHD-II 1.2.6) or hemiplegic (ICHD-II 1.2.4) migraine.
Item
Subject has basilar (ICHD-II 1.2.6) or hemiplegic (ICHD-II 1.2.4) migraine.
boolean
C0270860 (UMLS CUI [1])
C0270862 (UMLS CUI [2])
C0270862 (UMLS CUI [2])
impaired hepatic or renal function
Item
Subject has a history of impaired hepatic or renal function that, in the investigator ’ s opinion, contraindicates participation in this study
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C1565489 (UMLS CUI [2])
Subject has had headache > 15 days/month in either of the three months prior to screening
Item
Subject has had headache > 15 days/month in either of the three months prior to screening
boolean
C0018681 (UMLS CUI [1,1])
C0556971 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,2])
Subject has < 15 days/month of headache-free days in either of the three months prior to screening
Item
Subject has < 15 days/month of headache-free days in either of the three months prior to screening
boolean
C3843208 (UMLS CUI [1,1])
C0556971 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,2])
monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment
Item
Subject is currently taking a monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment
boolean
C0087111 (UMLS CUI [1,1])
C0026457 (UMLS CUI [1,2])
C0026457 (UMLS CUI [1,2])
migraine prophylactic medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide
Item
Subject is currently taking or has taken in the previous three months, a migraine prophylactic medication containing ergotamine, an ergot derivative (dihydroergotamine) or methysergide
boolean
C0420172 (UMLS CUI [1,1])
C0025842 (UMLS CUI [1,2])
C0012291 (UMLS CUI [1,3])
C0014710 (UMLS CUI [1,4])
C0025842 (UMLS CUI [1,2])
C0012291 (UMLS CUI [1,3])
C0014710 (UMLS CUI [1,4])
Subject is currently taking any anti-coagulant (e.g., Coumadin).
Item
Subject is currently taking any anti-coagulant (e.g., Coumadin).
boolean
C0699129 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,2])
herbal preparations containing St. John ’ s Wort
Item
Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John ’ s Wort (Hypericum perforatum)
boolean
C0936242 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0332256 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium
Item
Subject has hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of its components or any other 5-HT 1 receptor agonist.
boolean
C0337443 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0075632 (UMLS CUI [1,4])
C0027396 (UMLS CUI [1,5])
C0020517 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0075632 (UMLS CUI [1,4])
C0027396 (UMLS CUI [1,5])
history of allergic reactions
Item
Subject has a history of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, and nasal polyps.
boolean
C0020517 (UMLS CUI [1,1])
C2106654 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0027396 (UMLS CUI [1,4])
C0003211 (UMLS CUI [1,5])
C2106654 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0027396 (UMLS CUI [1,4])
C0003211 (UMLS CUI [1,5])
history of any gastrointestinal surgery
Item
Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
boolean
C0524722 (UMLS CUI [1,1])
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])
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])
Subject has a history of gastric bypass or stapling surgery
Item
Subject has a history of gastric bypass or stapling surgery
boolean
C0017125 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
GI ulceration in the past six months or gastrointestinal bleeding in the past year
Item
Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
boolean
C0237938 (UMLS CUI [1,1])
C4086728 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2,1])
C3828652 (UMLS CUI [2,2])
C4086728 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2,1])
C3828652 (UMLS CUI [2,2])
Subject has a history of inflammatory bowel disease
Item
Subject has a history of inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
Subject has a history of any bleeding disorder
Item
Subject has a history of any bleeding disorder
boolean
C0005779 (UMLS CUI [1])
antiplatelet agent
Item
Subject is taking any antiplatelet agent (except low-dose aspirin < 325 mg/day for cardioprotective reasons).
boolean
C1096021 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0445550 (UMLS CUI [1,4])
C0332300 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0445550 (UMLS CUI [1,4])
Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
Item
Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
boolean
C0003015 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
C0521942 (UMLS CUI [1,2])
Subject is pregnant, actively trying to become pregnant or breast-feeding
Item
Subject is pregnant, actively trying to become pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
alcohol or substance abuse
Item
Subject has evidence of alcohol or substance abuse within the last year which, in the investigator's judgement, will likely interfere with the study conduct, subject co-operation, or evaluation and interpretation of the study results
boolean
C0085762 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
C0038586 (UMLS CUI [1,2])
concurrent medical or psychiatric condition
Item
Subject has any concurrent medical or psychiatric condition which, in the investigator's opinion, may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in this clinical trial.
boolean
C0009488 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Investigational drug trial within the previous four weeks
Item
Subject has participated in an investigational drug trial within the previous four weeks (excepting a previous study evaluating Trexima in which case an interval of at least 7 days have elapsed since discharge from previous Trexima trial), or plans to participate in another study at any time during this study
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
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