ID

32012

Beschreibung

This ODM file contains the form to document the investigational product, the treatment confirmation and the randomisation-number. To be assessed at Day 1 of Period 1 and 2 (randomisation number only at Period 1). 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

Stichworte

Versionen (2)
  1. 08.10.18 08.10.18 -
  2. 11.10.18 11.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. Oktober 2018

DOI

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Lizenz

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

Englisch

Investigational Product, Treatment Confirmation, Randomisation-Number

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beschreibung

Visit Type

Datentyp

integer

Alias
UMLS CUI [1]
C3641100
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Beschreibung

The following list of abbreviations can be used to aid the completion of the appropriate items on the Investigational Product page. If the abbreviation you require is not present on these lists an alternative may be used. INVESTIGATIONAL PRODUCT Code Label 115 = Trexima tablet 116 = Imitrex tablet

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beschreibung

Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Beschreibung

Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Treatment Confirmation
Beschreibung

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschreibung

Treatment confirmation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If No, record reason(s)
Beschreibung

Reason for Treatment modification

Datentyp

text

Alias
UMLS CUI [1,1]
C2736765
UMLS CUI [1,2]
C0087111
Randomisation number
Beschreibung

Randomisation number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number
Beschreibung

To be assessed only at Day 1 of Period 1

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
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Ähnliche Modelle

Investigational Product, Treatment Confirmation, Randomisation-Number

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (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)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Treatment confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Reason for Treatment modification
Item
If No, record reason(s)
text
C2736765 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item Group
Randomisation number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation number
Item
Record randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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