ID

36951

Description

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Keywords

  1. 6/23/19 6/23/19 -
  2. 9/17/21 9/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 23, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146

  1. StudyEvent: ODM
    1. Screen
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Is the subject a healthy adult male or female between 18 and 55 years of age, inclusive?
Description

Health Status; Age; Gender

Data type

boolean

Alias
UMLS CUI [1]
C0018759
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
Is the subject male, or an eligible female?
Description

Female subjects are eligible for participation in the study if they are of: Yes No DD DD a) Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b) Childbearing potential, have a negative pregnancy test (urine or serum) at screening, and one of the following applies: • Agree to complete abstinence from intercourse for at least 14 days prior to first dose of study medication, throughout the study, and for a time interval after completion of the study or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 12.5 hours); 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 criteria); or, • Double barrier method (2 physical barriers or 1 physical barrier plus spermicidal); or • Any other method with published data showing that the lowest expected failure rate is less than 1% per year.

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0700589
Is the subject male, a female of non-childbearing potential, or a female taking oral contraceptives or HRT and has been on a stable regimen for at least 2 months prior to screening?
Description

Gender; Childbearing Potential; Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0700589
Is the subject's BMI 20-30 kg/m2, inclusive?
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Has a signed and dated written informed consent been obtained from the subject?
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Does the subject have any clinically relevant abnormality identified on the screening history and physical or laboratory examination?
Description

Abnormality, Clinically Significant Indicator

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Does the subject have a history of impaired hepatic or renal function?
Description

Liver Dysfunction, Medical History; Renal Insufficiency, Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0262926
Does the subject suffer from migraine attacks?
Description

Migraine Disorders

Data type

text

Alias
UMLS CUI [1]
C0149931
Does the subject have confirmed or suspected ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal’s angina or signs/symptoms consistent with any of the above?
Description

Myocardial Ischemia; Angina pectoris

Data type

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0002962
Does the subject have cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator’s opinion, contraindicates participation in this study?
Description

Cardiac Arrhythmia; Electrocardiography, Abnormality, Relevance, Clinical

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2,1]
C1623258
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C2347946
UMLS CUI [2,4]
C0205210
Does the subject have a history of congenital heart disease?
Description

Congenital heart disease, Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0152021
UMLS CUI [1,2]
C0262926
Does the subject have a history of cerebrovascular pathology including stroke?
Description

Cerebrovascular Disorders, Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0007820
UMLS CUI [1,2]
C0262926
Is the subject, in the investigator’s opinion, likely to have unrecognized cardiovascular or cerebrovascular disease?
Description

Cardiovascular Diseases; Cerebrovascular Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0007820
Does the subject have evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud Syndrome?
Description

Ischemic, Abdomen; Peripheral Vascular Disease; Raynaud Syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0022116
UMLS CUI [1,2]
C0000726
UMLS CUI [2]
C0085096
UMLS CUI [3]
C0034734
Does the subject have uncontrolled hypertension at screening (sitting systolic pressure >140mm/Hg, diastolic pressure >90mm/Hg)?
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
Has the subject had treatment with an investigational drug within 30 days preceding the first dose of study medication?
Description

Experimental drug, Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205156
Has the subject used other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication? NOTE: Excluded from this list are: acetaminophen at doses of <2 grams/day and contraceptives as detailed in Section 8.1 of the protocol).
Description

Pharmaceutical Preparations; Vitamins, Herbal supplements; Dietary Supplements

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0042890
UMLS CUI [3]
C1504473
UMLS CUI [4]
C0242295
Does the subject have a positive serum beta-human chorionic gonadotropin (β-hCG) test (females) at screening or check-in?
Description

Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0240802
Is the subject a pregnant or nursing female?
Description

Pregnancy; Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Does the subject have a history of drug or alcohol abuse?
Description

Drug Abuse; Alcohol Abuse

Data type

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0085762
Does the subject have a history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening?
Description

Alcohol consumption, Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
Does the subject have a positive urine drug screen (UDS) including alcohol at screening or check-in?
Description

Urine drug screen positive

Data type

boolean

Alias
UMLS CUI [1]
C0743300
Has the subject donated blood in excess of 500 mL within 56 days prior to first dose of study medication?
Description

Blood Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
Does the subject have a history of allergic, anaphylactic, hypersensitivity or idiosyncratic reaction(s) to sumatriptan or drugs of a similar type, including sulphonamides?
Description

Sumatriptan, Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0075632
UMLS CUI [1,2]
C0020517
Does the subject smoke more than 10 cigarettes per day?
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
Does the subject have a history of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof?
Description

Heparin, Hypersensitivity; Heparin-induced Thrombocytopenia; Experimental drug, Hypersensitivity

Data type

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0019134
UMLS CUI [2]
C0272285
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0020517
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of assessment
Description

Demography, Assessment date

Data type

date

Alias
UMLS CUI [1,1]
C0011298
UMLS CUI [1,2]
C2985720
Date of birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Racial group

Data type

text

Alias
UMLS CUI [1]
C0034510
Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005890
kg
Body mass index
Description

Body mass index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

Vital Signs Date

Data type

date

Alias
UMLS CUI [1]
C2826644
Blood pressure systolic
Description

Systolic Pressure

Data type

integer

Alias
UMLS CUI [1]
C0871470
Blood pressure diastolic
Description

Diastolic blood pressure

Data type

integer

Alias
UMLS CUI [1]
C0428883
Heart rate
Description

Heart rate

Data type

integer

Alias
UMLS CUI [1]
C0018810
Demography for Females
Description

Demography for Females

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C0015780
Childbearing potential
Description

Childbearing Potential

Data type

text

Alias
UMLS CUI [1]
C3831118
Pregnancy test result
Description

Pregnancy test finding

Data type

text

Alias
UMLS CUI [1]
C0427777
Medical history
Description

Medical history

Alias
UMLS CUI-1
C0262926
Organ
Description

Medical History, body system or organ function

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0678852
Medical Condition
Description

Mediacal History, Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012634
Description
Description

Mediacal History, Description

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0678257
Current Medical Conditions
Description

Current Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0521116
Organ
Description

Disease, Current, body system or organ function

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C0678852
Medical Condition?
Description

Disease, Current

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521116
Description
Description

Disease, Current, Description

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C0678257
Medication History
Description

Medication History

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0262926
Were any medications taken by the subject within 30 days prior to screening?
Description

Pharmaceutical Preparations, Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0262926
Drug (Trade name preferred)
Description

Pharmaceutical Preparations, Medical History, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C2360065
Date started
Description

Pharmaceutical Preparations, Medical History, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0808070
Check if started Pre-study
Description

Pharmaceutical Preparations, Medical History, Start Date, Pre-study

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0808070
Date stopped
Description

Pharmaceutical Preparations, Medical History, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0806020
if continued Post-study
Description

Pharmaceutical Preparations, Medical History, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0549178
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of assessment
Description

Physical Examination Date

Data type

date

Alias
UMLS CUI [1]
C2826643
Organ
Description

Physical Examination, body function or organ system

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0678852
Not Done
Description

Physical Examination, Not Done

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1272696
Normal or abnormal?
Description

Physical Examination, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1704258
Description
Description

Physical Examination, Description

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0678257
Electrocardiogram
Description

Electrocardiogram

Alias
UMLS CUI-1
C1623258
Date of ECG
Description

Electrocardiogram Date

Data type

date

Alias
UMLS CUI [1]
C2826640
Time
Description

Electrocardiogram, Time

Data type

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Ventricular rate/heart rate
Description

Electrocardiography, Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0018810
bpm
PR interval
Description

Electrocardiogram: P-R interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS duration
Description

Electrocardiography, QRS complex duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0429025
msec
QT interval
Description

Electrocardiography, QT interval - finding

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1287082
msec
QTc interval
Description

Electrocardiography, QTc interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0489625
msec
Abnormalities?
Description

Electrocardiography, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1704258
Were any of the abnormalities clinically significant?
Description

Electrocardiography, Abnormality, Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2826293
Rhythm
Description

Electrocardiography, Abnormality, Rhythm

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
P-Wave Morphology
Description

Electrocardiography, Abnormality, P-Wave shifting Morphology

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2216025
Conduction
Description

Electrocardiography, Abnormality, Cardiac Conduction

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Depolarization/Repolarization (QRS-T)
Description

Electrocardiography, Abnormality, Depolarization, Repolarization

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C3279217
Other
Description

Electrocardiography, Abnormality, Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
Comment
Description

Electrocardiography, Abnormality, Comment

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0947611
Laboratory Data Abnormalities - Hematology Abnormalities
Description

Laboratory Data Abnormalities - Hematology Abnormalities

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1704258
UMLS CUI-3
C0474523
Lab code
Description

Laboratory, Code

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0805701
Date hematology sample taken
Description

Laboratory Procedures, Hematology finding, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Time of sample
Description

Laboratory Procedures, Hematology finding, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Were there any clinically significant hematology abnormalities?
Description

Laboratory Procedures, Hematology finding, Abnormality, Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2826293
Laboratory Data Abnormalities - Clinical Chemistry Abnormalities
Description

Laboratory Data Abnormalities - Clinical Chemistry Abnormalities

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C1704258
Lab code
Description

Laboratory, Code

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0805701
Date clinical chemistry sample taken
Description

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Time of sample
Description

Laboratory Procedures, Chemistry, Clinical, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Were there any clinically significant clinical chemistry abnormalities?
Description

Laboratory Procedures, Chemistry, Clinical, Abnormality, Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2826293
Laboratory Data Abnormalities - Urinalysis Abnormalities
Description

Laboratory Data Abnormalities - Urinalysis Abnormalities

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0042014
UMLS CUI-3
C1704258
Lab code
Description

Laboratory, Code

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0805701
Date sample taken
Description

Laboratory Procedures, Urinalysis , Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Time of sample
Description

Laboratory Procedures, Urinalysis , Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Were there any clinically significant urinalysis abnormalities?
Description

Laboratory Procedures, Urinalysis, Abnormality, Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2826293
Drugs of Abuse
Description

Drugs of Abuse

Alias
UMLS CUI-1
C0013146
Date sample taken
Description

Drug screen, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Drug
Description

Drug screen, Illicit Drugs

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0086190
Result
Description

Drug screen, Result

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C1274040
Serology / HIV Screen
Description

Serology / HIV Screen

Alias
UMLS CUI-1
C0036743
UMLS CUI-2
C0459958
Date sample taken
Description

Serologic tests, HIV Screen, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0459958
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Hepatitis B surface antigen
Description

Serologic tests, Hepatitis B surface antigen

Data type

text

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0019168
Hepatitis C antibody
Description

Serologic tests, Hepatitis C antibody measurement

Data type

text

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201487
HIV antibody
Description

HIV screen, HIV antibodies

Data type

text

Alias
UMLS CUI [1,1]
C0459958
UMLS CUI [1,2]
C0019683
Treatment Assignment
Description

Treatment Assignment

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C1516050
Check the appropriate box to indicate the study cohort to which the subject is assigned:
Description

Therapeutic procedure, Assignment

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1516050

Similar models

Screen

  1. StudyEvent: ODM
    1. Screen
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Health Status; Age; Gender
Item
Is the subject a healthy adult male or female between 18 and 55 years of age, inclusive?
boolean
C0018759 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Gender; Childbearing Potential; Contraceptive methods
Item
Is the subject male, or an eligible female?
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Gender; Childbearing Potential; Contraceptive methods
Item
Is the subject male, a female of non-childbearing potential, or a female taking oral contraceptives or HRT and has been on a stable regimen for at least 2 months prior to screening?
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Body mass index
Item
Is the subject's BMI 20-30 kg/m2, inclusive?
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
Has a signed and dated written informed consent been obtained from the subject?
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Abnormality, Clinically Significant Indicator
Item
Does the subject have any clinically relevant abnormality identified on the screening history and physical or laboratory examination?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Liver Dysfunction, Medical History; Renal Insufficiency, Medical History
Item
Does the subject have a history of impaired hepatic or renal function?
boolean
C0086565 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Migraine Disorders
Item
Does the subject suffer from migraine attacks?
text
C0149931 (UMLS CUI [1])
Myocardial Ischemia; Angina pectoris
Item
Does the subject have confirmed or suspected ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal’s angina or signs/symptoms consistent with any of the above?
boolean
C0151744 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
Cardiac Arrhythmia; Electrocardiography, Abnormality, Relevance, Clinical
Item
Does the subject have 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
C0003811 (UMLS CUI [1])
C1623258 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
Congenital heart disease, Medical History
Item
Does the subject have a history of congenital heart disease?
boolean
C0152021 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Cerebrovascular Disorders, Medical History
Item
Does the subject have a history of cerebrovascular pathology including stroke?
boolean
C0007820 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Cardiovascular Diseases; Cerebrovascular Disorders
Item
Is the subject, in the investigator’s opinion, likely to have unrecognized cardiovascular or cerebrovascular disease?
boolean
C0007222 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
Ischemic, Abdomen; Peripheral Vascular Disease; Raynaud Syndrome
Item
Does the subject have evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud Syndrome?
boolean
C0022116 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0085096 (UMLS CUI [2])
C0034734 (UMLS CUI [3])
Uncontrolled hypertension
Item
Does the subject have uncontrolled hypertension at screening (sitting systolic pressure >140mm/Hg, diastolic pressure >90mm/Hg)?
boolean
C1868885 (UMLS CUI [1])
Experimental drug, Previous
Item
Has the subject had treatment with an investigational drug within 30 days preceding the first dose of study medication?
boolean
C0304229 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pharmaceutical Preparations; Vitamins, Herbal supplements; Dietary Supplements
Item
Has the subject used other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication? NOTE: Excluded from this list are: acetaminophen at doses of <2 grams/day and contraceptives as detailed in Section 8.1 of the protocol).
boolean
C0013227 (UMLS CUI [1])
C0042890 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
Pregnancy test positive
Item
Does the subject have a positive serum beta-human chorionic gonadotropin (β-hCG) test (females) at screening or check-in?
boolean
C0240802 (UMLS CUI [1])
Pregnancy; Breast Feeding
Item
Is the subject a pregnant or nursing female?
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Drug Abuse; Alcohol Abuse
Item
Does the subject have a history of drug or alcohol abuse?
boolean
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Alcohol consumption, Regular
Item
Does the subject have a history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening?
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Urine drug screen positive
Item
Does the subject have a positive urine drug screen (UDS) including alcohol at screening or check-in?
boolean
C0743300 (UMLS CUI [1])
Blood Donation
Item
Has the subject donated blood in excess of 500 mL within 56 days prior to first dose of study medication?
boolean
C0005794 (UMLS CUI [1])
Sumatriptan, Hypersensitivity
Item
Does the subject have a history of allergic, anaphylactic, hypersensitivity or idiosyncratic reaction(s) to sumatriptan or drugs of a similar type, including sulphonamides?
boolean
C0075632 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Tobacco use
Item
Does the subject smoke more than 10 cigarettes per day?
boolean
C0543414 (UMLS CUI [1])
Heparin, Hypersensitivity; Heparin-induced Thrombocytopenia; Experimental drug, Hypersensitivity
Item
Does the subject have a history of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof?
text
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
C0304229 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Demography, Assessment date
Item
Date of assessment
date
C0011298 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
American Hispanic (4)
CL Item
Other (5)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005890 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs Date
Item
Date
date
C2826644 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Demography for Females
C0011298 (UMLS CUI-1)
C0015780 (UMLS CUI-2)
Item
Childbearing potential
text
C3831118 (UMLS CUI [1])
Code List
Childbearing potential
CL Item
Premenarcheal  (1)
CL Item
Sterile (of childbearing age)  (2)
CL Item
Postmenopausal (3)
CL Item
Potentially able to conceive children (4)
Item
Pregnancy test result
text
C0427777 (UMLS CUI [1])
Code List
Pregnancy test result
CL Item
Positive  (1)
CL Item
Negative  (2)
CL Item
Not applicable (3)
Item Group
Medical history
C0262926 (UMLS CUI-1)
Item
Organ
text
C0262926 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
CL Item
Ear, Nose and Throat (1)
CL Item
Eyes (2)
CL Item
Respiratory (3)
CL Item
Cardiovascular (4)
CL Item
Gastrointestinal (5)
CL Item
Hepatobiliary and pancreas (6)
CL Item
Urology (7)
CL Item
Reproduction (8)
CL Item
Neurology (9)
CL Item
Blood and lymphatic (10)
CL Item
Endocrine and metabolic (11)
CL Item
Muskuloskeletal (12)
CL Item
Skin (13)
CL Item
Psychiatry (14)
CL Item
Allergies (15)
Mediacal History, Disease
Item
Medical Condition
boolean
C0262926 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Mediacal History, Description
Item
Description
text
C0262926 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Current Medical Conditions
C0012634 (UMLS CUI-1)
C0521116 (UMLS CUI-2)
Item
Organ
text
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0678852 (UMLS CUI [1,3])
CL Item
Ear, Nose and Throat (1)
CL Item
Eyes (2)
CL Item
Respiratory (3)
CL Item
Cardiovascular (4)
CL Item
Gastrointestinal (5)
CL Item
Hepatobiliary and pancreas (6)
CL Item
Urology (7)
CL Item
Reproduction (8)
CL Item
Neurology (9)
CL Item
Blood and lymphatic (10)
CL Item
Endocrine and metabolic (11)
CL Item
Muskuloskeletal (12)
CL Item
Skin (13)
CL Item
Psychiatry (14)
CL Item
Allergies (15)
Disease, Current
Item
Medical Condition?
boolean
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Disease, Current, Description
Item
Description
text
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item Group
Medication History
C0013227 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Pharmaceutical Preparations, Medical History
Item
Were any medications taken by the subject within 30 days prior to screening?
boolean
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Pharmaceutical Preparations, Medical History, Medication name
Item
Drug (Trade name preferred)
text
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Pharmaceutical Preparations, Medical History, Start Date
Item
Date started
date
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Pharmaceutical Preparations, Medical History, Start Date, Pre-study
Item
Check if started Pre-study
boolean
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Pharmaceutical Preparations, Medical History, End Date
Item
Date stopped
date
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Pharmaceutical Preparations, Medical History, Continuous
Item
if continued Post-study
boolean
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination Date
Item
Date of assessment
date
C2826643 (UMLS CUI [1])
Item
Organ
text
C0031809 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
CL Item
Hair and Skin (1)
CL Item
Lymph nodes (2)
CL Item
Eyes (3)
CL Item
Ears, Nose and Throat (4)
CL Item
Breasts (5)
CL Item
Respiratory (6)
CL Item
Cardiovascular (7)
CL Item
Abdomen (8)
CL Item
Urogenital (9)
CL Item
Pelvic (10)
CL Item
Rectal (11)
CL Item
Musculoskeletal (12)
CL Item
Neurological (13)
CL Item
Mental Status (14)
Physical Examination, Not Done
Item
Not Done
boolean
C0031809 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item
Normal or abnormal?
text
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Normal or abnormal?
CL Item
Normal  (1)
CL Item
Abnormal (2)
Physical Examination, Description
Item
Description
text
C0031809 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Electrocardiogram
C1623258 (UMLS CUI-1)
Electrocardiogram Date
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Electrocardiogram, Time
Item
Time
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Electrocardiography, Heart rate
Item
Ventricular rate/heart rate
integer
C1623258 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Electrocardiogram: P-R interval
Item
PR interval
integer
C0429087 (UMLS CUI [1])
Electrocardiography, QRS complex duration
Item
QRS duration
integer
C1623258 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
Electrocardiography, QT interval - finding
Item
QT interval
integer
C1623258 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
Electrocardiography, QTc interval
Item
QTc interval
integer
C1623258 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
Item
Abnormalities?
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Abnormalities?
CL Item
Normal (1)
CL Item
Abnormalities present (2)
Electrocardiography, Abnormality, Clinical Significance
Item
Were any of the abnormalities clinically significant?
boolean
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Item
Rhythm
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
CL Item
Sinus bradycardia (1)
CL Item
Sinus tachycardia  (2)
CL Item
Sinus pause  (3)
CL Item
Ectopic supraventricular beats  (4)
CL Item
Junctional rhythm (≤100/min)  (5)
CL Item
Supraventricular tachycardia (>100/min)  (6)
CL Item
Atrial flutter  (7)
CL Item
Atrial fibrillation  (8)
CL Item
Ectopic ventricular beats  (9)
CL Item
Ventricular rhythm, comment below  (10)
CL Item
Pacemaker (11)
Item
P-Wave Morphology
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
Code List
P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
Item
Conduction
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
CL Item
First degree AV block (PR interval >0.20sec)  (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
Third degree AV block (4)
CL Item
Left axis deviation (QRS axis more negative than - 30 degrees) (5)
CL Item
Right axis deviation (QRS axis more positive than + 110 degrees) (6)
CL Item
Incomplete right bundle branch block (7)
CL Item
Right bundle branch block (8)
CL Item
Left bundle branch block (9)
CL Item
Nonspecific intraventricular conduction delay (QRS ≥0.12sec) (10)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine) (12)
CL Item
QT/QTc prolongation (13)
Item
Depolarization/Repolarization (QRS-T)
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C3279217 (UMLS CUI [1,4])
Code List
Depolarization/Repolarization (QRS-T)
CL Item
Myocardial infarction, old  (1)
CL Item
Myocardial infarction, other (2)
CL Item
Non-specific ST-T changes  (3)
CL Item
Low QRS voltage (4)
Electrocardiography, Abnormality, Other
Item
Other
boolean
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Electrocardiography, Abnormality, Comment
Item
Comment
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Laboratory Data Abnormalities - Hematology Abnormalities
C0022885 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0474523 (UMLS CUI-3)
Laboratory, Code
Item
Lab code
text
C0022877 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding, Sampling, Date in time
Item
Date hematology sample taken
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Sampling, Time
Item
Time of sample
time
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Abnormality, Clinical Significance
Item
Were there any clinically significant hematology abnormalities?
boolean
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Item Group
Laboratory Data Abnormalities - Clinical Chemistry Abnormalities
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C1704258 (UMLS CUI-3)
Laboratory, Code
Item
Lab code
text
C0022877 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Item
Date clinical chemistry sample taken
date
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Sampling, Time
Item
Time of sample
time
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Abnormality, Clinical Significance
Item
Were there any clinically significant clinical chemistry abnormalities?
boolean
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Item Group
Laboratory Data Abnormalities - Urinalysis Abnormalities
C0022885 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
C1704258 (UMLS CUI-3)
Laboratory, Code
Item
Lab code
text
C0022877 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Laboratory Procedures, Urinalysis , Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Urinalysis , Sampling, Time
Item
Time of sample
time
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Urinalysis, Abnormality, Clinical Significance
Item
Were there any clinically significant urinalysis abnormalities?
boolean
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Item Group
Drugs of Abuse
C0013146 (UMLS CUI-1)
Drug screen, Sampling, Date in time
Item
Date sample taken
date
C0373483 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Drug
text
C0373483 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
CL Item
Opiates (1)
CL Item
Benzoylecgonine (cocaine metabolite) (2)
CL Item
Barbiturates  (3)
CL Item
Amphetamines  (4)
CL Item
Benzodiazepines  (5)
CL Item
Cannabinoids (6)
CL Item
Alcohol (7)
Item
Result
text
C0373483 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Serology / HIV Screen
C0036743 (UMLS CUI-1)
C0459958 (UMLS CUI-2)
Serologic tests, HIV Screen, Sampling, Date in time
Item
Date sample taken
date
C0036743 (UMLS CUI [1,1])
C0459958 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Hepatitis B surface antigen
text
C0036743 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
text
C0036743 (UMLS CUI [1,1])
C0201487 (UMLS CUI [1,2])
Code List
Hepatitis C antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
HIV antibody
text
C0459958 (UMLS CUI [1,1])
C0019683 (UMLS CUI [1,2])
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Treatment Assignment
C0087111 (UMLS CUI-1)
C1516050 (UMLS CUI-2)
Item
Check the appropriate box to indicate the study cohort to which the subject is assigned:
text
C0087111 (UMLS CUI [1,1])
C1516050 (UMLS CUI [1,2])
Code List
Check the appropriate box to indicate the study cohort to which the subject is assigned:
CL Item
Regimen A  (1)
CL Item
Regimen B (2)
CL Item
Regimen C (3)

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