ID

37112

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. 7/3/19 7/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 3, 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

English

End of Study Record

1 forms  
  1. StudyEvent: ODM
    1. End of Study Record
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
End of Study Record
Description

End of Study Record

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0444930
Date of subject completion or discontinuation from the study
Description

Clinical Trials, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0806020
Did the subject become pregnant during the study?
Description

Pregnancy, During, Clinical Trials

Data type

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Did the subject discontinue the study prematurely?
Description

Continuation status, Clinical Trials

Data type

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
If YES, check the primary reason for discontinuation.
Description

Continuation Status, Clinical Trials, Reason

Data type

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Specify
Description

Continuation Status, Clinical Trials, Reason

Data type

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
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Similar models

End of Study Record

1 forms
  1. StudyEvent: ODM
    1. End of Study Record
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
End of Study Record
C0008976 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Clinical Trials, End Date
Item
Date of subject completion or discontinuation from the study
date
C0008976 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Pregnancy, During, Clinical Trials
Code List
Did the subject become pregnant during the study?
CL Item
Not applicable (1)
CL Item
Yes (2)
CL Item
No (3)
Continuation status, Clinical Trials
Item
Did the subject discontinue the study prematurely?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
If YES, check the primary reason for discontinuation.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation Status, Clinical Trials, Reason
Code List
If YES, check the primary reason for discontinuation.
CL Item
Adverse event  (1)
CL Item
Consent Withdrawn (2)
CL Item
Lost to follow up  (3)
CL Item
Protocol violation (4)
CL Item
Other, specify (5)
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation Status, Clinical Trials, Reason
Code List
Specify
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