ID

36965

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-06-24 2019-06-24 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

24 juni 2019

DOI

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Licens

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

Engelsk

Investigational Product Discontinuation

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Investigational Product Discontinuation
Beskrivning

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0805733
Was the investigational product stopped permanently before the end of the scheduled dosing period?
Beskrivning

Experimental drug, Discontinued

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1444662
If YES, check the primary reason the investigational product was stopped, check one
Beskrivning

Experimental drug, Discontinued, Reason and justification

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0566251
Specify
Beskrivning

Experimental drug, Discontinued, Reason and justification

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0566251
Tillbaka till toppen

Similar models

Investigational Product Discontinuation

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0805733 (UMLS CUI-2)
Experimental drug, Discontinued
Item
Was the investigational product stopped permanently before the end of the scheduled dosing period?
boolean
C0304229 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Item
If YES, check the primary reason the investigational product was stopped, check one
text
C0304229 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Experimental drug, Discontinued, Reason and justification
Code List
If YES, check the primary reason the investigational product was stopped, check one
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 (5)
Experimental drug, Discontinued, Reason and justification
Item
Specify
text
C0304229 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Tillbaka till toppen 

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