ID

36965

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

Investigational Product Discontinuation

1 formularios  
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
Investigational Product Discontinuation
Descripción

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?
Descripción

Experimental drug, Discontinued

Tipo de datos

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
Descripción

Experimental drug, Discontinued, Reason and justification

Tipo de datos

text

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

Experimental drug, Discontinued, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0566251
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Similar models

Investigational Product Discontinuation

1 formularios
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
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])
Volver a la parte superior de la página 

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