ID

37113

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. 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

Investigator Comment Log

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
Investigator Comment Log
Description

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
Date of comment
Description

Clinical Investigators, Comment, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C0011008
CRF page number if applicable
Description

Clinical Investigators, Comment, CRF, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C1516308
UMLS CUI [1,4]
C0237753
Comment
Description

Clinical Investigators, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C1516308
UMLS CUI [1,4]
C0237753

Similar models

Investigator Comment Log

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
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Clinical Investigators, Comment, Date in time
Item
Date of comment
date
C0008961 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Clinical Investigators, Comment, CRF, Numbers
Item
CRF page number if applicable
integer
C0008961 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C1516308 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Clinical Investigators, Comment
Item
Comment
text
C0008961 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C1516308 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])

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