ID

36957

Descripción

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

Palabras clave

Versiones (1)
  1. 23/6/19 23/6/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

23 de junio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146

Inglés

Follow-Up

1 formularios  
  1. StudyEvent: ODM
    1. Follow-Up
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Prepgnancy Test
Descripción

Prepgnancy Test

Alias
UMLS CUI-1
C0032976
Is a pregnancy test applicable?
Descripción

Pregnancy Tests, Applicable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1706839
If YES, was pregnancy test performed?
Descripción

Pregnancy Tests, Diagnostic procedures performed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C3259360
Date pregnancy sample taken
Descripción

Pregnancy Tests, Sampling, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
If YES, pregnancy test result, check one
Descripción

Pregnancy Tests, Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Descripción

Vital Signs Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826644
Blood pressure systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Alias
UMLS CUI [1]
C0871470
Blood pressure diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Alias
UMLS CUI [1]
C0428883
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018810
Electrocardiogram
Descripción

Electrocardiogram

Alias
UMLS CUI-1
C1623258
Date of ECG
Descripción

Electrocardiogram Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826640
Time
Descripción

Electrocardiogram, Time

Tipo de datos

time

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

Electrocardiography, Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0018810
bpm
PR interval
Descripción

Electrocardiogram: P-R interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS duration
Descripción

Electrocardiography, QRS complex duration

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0429025
msec
QT interval
Descripción

Electrocardiography, QT interval - finding

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1287082
msec
QTc interval
Descripción

Electrocardiography, QTc interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0489625
msec
Abnormalities?
Descripción

Electrocardiography, Abnormality

Tipo de datos

text

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

Electrocardiography, Abnormality, Clinical Significance

Tipo de datos

boolean

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

Electrocardiography, Abnormality, Rhythm

Tipo de datos

text

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

Electrocardiography, Abnormality, P-Wave shifting Morphology

Tipo de datos

text

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

Electrocardiography, Abnormality, Cardiac Conduction

Tipo de datos

text

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

Electrocardiography, Abnormality, Depolarization, Repolarization

Tipo de datos

text

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

Electrocardiography, Abnormality, Other

Tipo de datos

boolean

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

Electrocardiography, Abnormality, Comment

Tipo de datos

text

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

Laboratory Data Abnormalities - Hematology Abnormalities

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

Laboratory, Code

Tipo de datos

text

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

Laboratory Procedures, Hematology finding, Sampling, Date in time

Tipo de datos

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
Descripción

Laboratory Procedures, Hematology finding, Sampling, Time

Tipo de datos

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?
Descripción

Laboratory Procedures, Hematology finding, Abnormality, Clinical Significance

Tipo de datos

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
Descripción

Laboratory Data Abnormalities - Clinical Chemistry Abnormalities

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

Laboratory, Code

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Laboratory Procedures, Chemistry, Clinical, Sampling, Time

Tipo de datos

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?
Descripción

Laboratory Procedures, Chemistry, Clinical, Abnormality, Clinical Significance

Tipo de datos

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
Descripción

Laboratory Data Abnormalities - Urinalysis Abnormalities

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

Laboratory, Code

Tipo de datos

text

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

Laboratory Procedures, Urinalysis , Sampling, Date in time

Tipo de datos

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
Descripción

Laboratory Procedures, Urinalysis , Sampling, Time

Tipo de datos

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?
Descripción

Laboratory Procedures, Urinalysis, Abnormality, Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2826293
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Similar models

Follow-Up

1 formularios
  1. StudyEvent: ODM
    1. Follow-Up
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Prepgnancy Test
C0032976 (UMLS CUI-1)
Pregnancy Tests, Applicable
Item
Is a pregnancy test applicable?
boolean
C0032976 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
Pregnancy Tests, Diagnostic procedures performed
Item
If YES, was pregnancy test performed?
boolean
C0032976 (UMLS CUI [1,1])
C3259360 (UMLS CUI [1,2])
Pregnancy Tests, Sampling, Date in time
Item
Date pregnancy sample taken
date
C0032976 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If YES, pregnancy test result, check one
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy Tests, Result
Code List
If YES, pregnancy test result, check one
CL Item
Positive (1)
CL Item
Negative (2)
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
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])
Electrocardiography, Abnormality
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])
Electrocardiography, Abnormality, Rhythm
Code List
Rhythm
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])
Electrocardiography, Abnormality, Rhythm
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])
Electrocardiography, Abnormality, Rhythm
Code List
Conduction
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])
Electrocardiography, Abnormality, Rhythm
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])
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