ID

36956

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

Versions (1)
  1. 6/23/19 6/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 23, 2019

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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

English

Dosing Session 3

1 forms  
  1. StudyEvent: ODM
    1. Dosing Session 3
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
Pregnancy Test
Description

Pregnancy Test

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

Pregnancy Tests, Applicable

Data type

boolean

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

Pregnancy Tests, Diagnostic procedures performed

Data type

boolean

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

Pregnancy Tests, Sampling, Date in time

Data type

date

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

Pregnancy Tests, Result

Data type

text

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

Vital Signs Date

Data type

date

Alias
UMLS CUI [1]
C2826644
Planned Time
Description

Vital Signs Time, Planned

Data type

text

Alias
UMLS CUI [1,1]
C2826762
UMLS CUI [1,2]
C1301732
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
Pharmacokinetic Sampling
Description

Pharmacokinetic Sampling

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0870078
Row number
Description

Pharmacokinetic aspects, Sampling, Numbers

Data type

text

Alias
UMLS CUI [1,1]
C0851347
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0237753
Date
Description

Pharmacokinetic aspects, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Planned relative time
Description

Pharmacokinetic aspects, Sampling, Relative time, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0851347
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1301732
Actual time
Description

Pharmacokinetic aspects, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Sample number
Description

Pharmacokinetic aspects, Sampling, Numbers

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0237753
5 mL sample, check if taken
Description

Pharmacokinetic aspects, Sampling, Taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1883727
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Start Date
Description

Experimental drug, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Stop Date
Description

Experimental drug, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Were there any significant changes to investigational product?
Description

Experimental drug, Changed status

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0443172
If YES, specify investigational product changes, dates, and reasons
Description

Experimental drug, Changed status, Details

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C1522508
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Similar models

Dosing Session 3

1 forms
  1. StudyEvent: ODM
    1. Dosing Session 3
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
Pregnancy 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
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])
Drug screen, Illicit Drugs
Code List
Drug
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])
Drug screen, Result
Code List
Result
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])
Item
Planned Time
text
C2826762 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Vital Signs Time, Planned
Code List
Planned Time
CL Item
Pre-dose (1)
CL Item
15 min Post-dose (2)
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
Pharmacokinetic Sampling
C0031328 (UMLS CUI-1)
C0870078 (UMLS CUI-2)
Item
Row number
text
C0851347 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Pharmacokinetic aspects, Sampling, Relative time, Planned
Code List
Row number
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
Pharmacokinetic aspects, Sampling, Date in time
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Planned relative time
text
C0851347 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Pharmacokinetic aspects, Sampling, Relative time, Planned
Code List
Planned relative time
CL Item
Pre-dose (1)
CL Item
Record time of dose of Investigational Product (2)
CL Item
2 min post-dose (3)
CL Item
5 min post-dose (4)
CL Item
10 min post-dose (5)
CL Item
15 min post-dose (6)
CL Item
20 min post-dose (7)
CL Item
30 min post-dose (8)
CL Item
45 min post-dose (9)
CL Item
60 min post-dose (10)
CL Item
1.25 hr post-dose (11)
CL Item
1.5 hr post-dose (12)
CL Item
2 hr post-dose (13)
CL Item
2.5 hr post-dose (14)
CL Item
3 hr post-dose (15)
CL Item
4 hr post-dose (16)
CL Item
6 hr post-dose (17)
CL Item
8 hr post-dose (18)
CL Item
12 hr post-dose (19)
Pharmacokinetic aspects, Sampling, Time
Item
Actual time
time
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Sample number
text
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Pharmacokinetic aspects, Sampling, Numbers
Code List
Sample number
CL Item
BLD037 (1)
CL Item
- (2)
CL Item
BLD038 (3)
CL Item
BLD039 (4)
CL Item
BLD040 (5)
CL Item
BLD041 (6)
CL Item
BLD042 (7)
CL Item
BLD043 (8)
CL Item
BLD044 (9)
CL Item
BLD045 (10)
CL Item
BLD046 (11)
CL Item
BLD047 (12)
CL Item
BLD048 (13)
CL Item
BLD049 (14)
CL Item
BLD050 (15)
CL Item
BLD051 (16)
CL Item
BLD052 (17)
CL Item
BLD053 (18)
CL Item
BLD054 (19)
Pharmacokinetic aspects, Sampling, Taken
Item
5 mL sample, check if taken
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Experimental drug, Start Date
Item
Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Experimental drug, End Date
Item
Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Experimental drug, Changed status
Item
Were there any significant changes to investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Experimental drug, Changed status, Details
Item
If YES, specify investigational product changes, dates, and reasons
text
C0304229 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
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