ID

36966

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. 24/6/19 24/6/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

24 de junio de 2019

DOI

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Licencia

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

Inglés

Unscheduled

1 formularios  
  1. StudyEvent: ODM
    1. Unscheduled
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
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
Lab name
Descripción

Performing laboratory name

Tipo de datos

text

Alias
UMLS CUI [1]
C3258037
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
Hematology
Descripción

Laboratory Procedures, Hematology finding

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
Results
Descripción

Laboratory Procedures, Hematology finding, Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1274040
Primary reason for clinically significant abnormality
Descripción

Laboratory Procedures, Hematology finding, Abnormality, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0566251
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
Lab name
Descripción

Performing laboratory name

Tipo de datos

text

Alias
UMLS CUI [1]
C3258037
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
Clinical chemistry
Descripción

Laboratory Procedures, Chemistry, Clinical

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
Results
Descripción

Laboratory Procedures, Chemistry, Clinical, Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1274040
Primary reason for clinically significant abnormality
Descripción

Laboratory Procedures, Chemistry, Clinical, Abnormality, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0566251
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
Lab name
Descripción

Performing laboratory name

Tipo de datos

text

Alias
UMLS CUI [1]
C3258037
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
Urinalysis
Descripción

Laboratory Procedures, Urinalysis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
Results
Descripción

Laboratory Procedures, Urinalysis, Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1274040
Primary reason for clinically significant abnormality
Descripción

Laboratory Procedures, Urinalysis, Abnormality, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0566251
Was sediment microscopy performed?
Descripción

Laboratory Procedures, Microscopic urinalysis, Urine Sediment Analysis Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0430397
UMLS CUI [1,3]
C2700128
Sediment microscopy
Descripción

Laboratory Procedures, Microscopic urinalysis, Urine Sediment Analysis Measurement

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0430397
UMLS CUI [1,3]
C2700128
Results
Descripción

Laboratory Procedures, Microscopic urinalysis, Urine Sediment Analysis Measurement, Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0430397
UMLS CUI [1,3]
C2700128
UMLS CUI [1,4]
C1274040
Primary reason for clinically significant abnormality
Descripción

Laboratory Procedures, Microscopic urinalysis, Urine Sediment Analysis Measurement, Abnormality, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0430397
UMLS CUI [1,3]
C2700128
UMLS CUI [1,4]
C1704258
UMLS CUI [1,5]
C0566251
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Similar models

Unscheduled

1 formularios
  1. StudyEvent: ODM
    1. Unscheduled
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
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])
Performing laboratory name
Item
Lab name
text
C3258037 (UMLS CUI [1])
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
Hematology
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding
Code List
Hematology
CL Item
Hemoglobin (1)
CL Item
Hematocrit (2)
CL Item
RCB (3)
CL Item
Platelets (4)
CL Item
Total WBC (5)
CL Item
Neutrophils (6)
CL Item
Lymphocytes (7)
CL Item
Monocytes (8)
CL Item
Eosinophils (9)
CL Item
Basophils (10)
CL Item
Bands (11)
Item
Results
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding
Code List
Results
Laboratory Procedures, Hematology finding, Abnormality, Reason and justification
Item
Primary reason for clinically significant abnormality
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0566251 (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])
Performing laboratory name
Item
Lab name
text
C3258037 (UMLS CUI [1])
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
Clinical chemistry
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding
Code List
Clinical chemistry
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Calcium (5)
CL Item
Glucose (6)
CL Item
Total protein (7)
CL Item
Albumin (8)
CL Item
Creatinine (9)
CL Item
Urea (BUN) (10)
CL Item
Total bilirubin (11)
CL Item
Alkaline phosphatase (12)
CL Item
GGT (13)
CL Item
AST (SGOT) (14)
CL Item
ALT (SGPT) (15)
CL Item
Phosphorus (inorganic) (16)
CL Item
Total cholesterol (17)
Laboratory Procedures, Chemistry, Clinical, Result
Item
Results
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Chemistry, Clinical, Abnormality, Reason and justification
Item
Primary reason for clinically significant abnormality
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0566251 (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])
Performing laboratory name
Item
Lab name
text
C3258037 (UMLS CUI [1])
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
Urinalysis
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding
Code List
Urinalysis
CL Item
Protein (1)
CL Item
pH (2)
CL Item
Specific gravity (3)
CL Item
Ketones (4)
CL Item
Glucose (5)
CL Item
Microscopic (6)
CL Item
Color (7)
CL Item
Casts/HPF (8)
Laboratory Procedures, Urinalysis, Result
Item
Results
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Urinalysis, Abnormality, Reason and justification
Item
Primary reason for clinically significant abnormality
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Laboratory Procedures, Microscopic urinalysis, Urine Sediment Analysis Measurement
Item
Was sediment microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,3])
Item
Sediment microscopy
text
C0022885 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding
Code List
Sediment microscopy
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
CL Item
Bacteria (6)
Laboratory Procedures, Microscopic urinalysis, Urine Sediment Analysis Measurement, Result
Item
Results
text
C0022885 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Laboratory Procedures, Microscopic urinalysis, Urine Sediment Analysis Measurement, Abnormality, Reason and justification
Item
Primary reason for clinically significant abnormality
text
C0022885 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
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