ID

31897

Descripción

This ODM file contains the form to collect data about the substance use of the patient. To be assessed at Day -1 of Period 1 and 2. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Palabras clave

Versiones (1)
  1. 7/10/18 7/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

7 de octubre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396

Inglés

Drug and Alcohol Screen, Urine Cotinine Test

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Type
Descripción

Visit Type

Tipo de datos

integer

Alias
UMLS CUI [1]
C3641100
Subject identifier
Descripción

Subject identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Drug and Alcohol Screen
Descripción

Drug and Alcohol Screen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0038586
UMLS CUI-3
C0948726
Date sample taken
Descripción

Date sample taken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1302413
Time sample taken
Descripción

Time sample taken

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Cocaine
Descripción

If positive, exclude subject from the study.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0009170
Amphetamines
Descripción

If positive, exclude subject from the study.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0002667
Benzodiazepines
Descripción

If positive, exclude subject from the study.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005064
Cannabinoids
Descripción

If positive, exclude subject from the study.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0936079
UMLS CUI [1,2]
C0870883
Opiates
Descripción

If positive, exclude subject from the study.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0376196
Barbiturates
Descripción

If positive, exclude subject from the study.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0004745
Alcohol
Descripción

If any of the above are positive, exclude subject from the study.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0202304
UMLS CUI [2]
C0001948
Laboratory Tests - Urine Cotinine
Descripción

Laboratory Tests - Urine Cotinine

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1697737
Date sample taken
Descripción

Date sample taken

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Results
Descripción

Urine Cotinine test results

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1697737
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Similar models

Drug and Alcohol Screen, Urine Cotinine Test

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Visit Type
integer
C3641100 (UMLS CUI [1])
Visit Type
Code List
Visit Type
CL Item
Day-1 of Period 1 (1)
CL Item
Day-1 of Period 2 (2)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Drug and Alcohol Screen
C0373483 (UMLS CUI-1)
C0038586 (UMLS CUI-2)
C0948726 (UMLS CUI-3)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Cocaine
integer
C0009170 (UMLS CUI [1])
Cocaine
Code List
Cocaine
CL Item
positive (1)
CL Item
negative (2)
Item
Amphetamines
integer
C0002667 (UMLS CUI [1])
Cocaine
Code List
Amphetamines
CL Item
positive (1)
CL Item
negative (2)
Item
Benzodiazepines
integer
C0005064 (UMLS CUI [1])
Cocaine
Code List
Benzodiazepines
CL Item
positive (1)
CL Item
negative (2)
Item
Cannabinoids
integer
C0936079 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
Cocaine
Code List
Cannabinoids
CL Item
positive (1)
CL Item
negative (2)
Item
Opiates
integer
C0376196 (UMLS CUI [1])
Cocaine
Code List
Opiates
CL Item
positive (1)
CL Item
negative (2)
Item
Barbiturates
integer
C0004745 (UMLS CUI [1])
Cocaine
Code List
Barbiturates
CL Item
positive (1)
CL Item
negative (2)
Item
Alcohol
integer
C0202304 (UMLS CUI [1])
C0001948 (UMLS CUI [2])
Cocaine
Code List
Alcohol
CL Item
positive (1)
CL Item
negative (2)
Item Group
Laboratory Tests - Urine Cotinine
C0022885 (UMLS CUI-1)
C1697737 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Results
integer
C1254595 (UMLS CUI [1,1])
C1697737 (UMLS CUI [1,2])
Urine Cotinine test results
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
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