ID

33048

Beskrivning

This form contains a form to document the randomisation number, investigational products and the pharmacokinetics. To be assessed at the visits V1-3. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 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

Länk

https://clinicaltrials.gov/ct2/show/NCT00875784

Nyckelord

Versioner (3)
  1. 2018-11-18 2018-11-18 -
  2. 2018-11-25 2018-11-25 -
  3. 2018-11-25 2018-11-25 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

25 november 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784

Engelsk

Randomisation Number, Investigational Products, Pharmacokinetics Blood

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beskrivning

Visit Type

Datatyp

text

Alias
UMLS CUI [1]
C3641100
Randomisation Number (Only Visit 1)
Beskrivning

Randomisation Number (Only Visit 1)

Alias
UMLS CUI-1
C1300638
UMLS CUI-2
C0034656
Was the subject able to be randomised?
Beskrivning

Subject's randomisation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0034656
In case the subject was able to be randomised, provide: Randomisation number
Beskrivning

Randomisation number

Datatyp

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0034656
In case the subject was able to be randomised, provide: Date of randomisation
Beskrivning

Date of randomisation

Datatyp

date

Alias
UMLS CUI [1]
C0034656
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Date/time of dose
Beskrivning

Date/time of dose

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1264639
Treatment Confirmation
Beskrivning

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?
Beskrivning

Receivement of the correct treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
In case the subject did not receive the correct treatment: record reason(s)
Beskrivning

Reason(s) in case the subject did not receive the correct treatment

Datatyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0392360
Dosing Date and Time
Beskrivning

Dosing Date and Time

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C1264639
Dosing date/time
Beskrivning

Dosing date/time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
Pharmacokinetics Blood
Beskrivning

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planend relative time
Beskrivning

Planned relative time of blood sample collection for pharmacokinetics analysis

Datatyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005834
Actual time
Beskrivning

To be assessed for all timepoints up to 4 hours post-dose (included)

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005834
Actual date/time
Beskrivning

To be assessed for all timepoints from 6 hours post-dose on (included).

Datatyp

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005834
Tillbaka till toppen

Similar models

Randomisation Number, Investigational Products, Pharmacokinetics Blood

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit Type
text
C3641100 (UMLS CUI [1])
Visit Type
Code List
Visit Type
CL Item
V1 (V1)
CL Item
V2 (V2)
CL Item
V3 (V3)
Item Group
Randomisation Number (Only Visit 1)
C1300638 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Subject's randomisation
Item
Was the subject able to be randomised?
boolean
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Randomisation number
Item
In case the subject was able to be randomised, provide: Randomisation number
text
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Date of randomisation
Item
In case the subject was able to be randomised, provide: Date of randomisation
date
C0034656 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date/time of dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Receivement of the correct treatment
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(s) in case the subject did not receive the correct treatment
Item
In case the subject did not receive the correct treatment: record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Dosing Date and Time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Pharmacokinetics Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planend relative time
text
C0439564 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Timepoint
Code List
Planend relative time
CL Item
Pre-dose (Pre-dose)
CL Item
0.5 hours (0.5 hours)
CL Item
0.75 hours (0.75 hours)
CL Item
1 hour (1 hour)
CL Item
1.5 hours (1.5 hours)
CL Item
2 hours (2 hours)
CL Item
2.17 hours (2.17 hours)
CL Item
2.25 hours (2.25 hours)
CL Item
2.5 hours (2.5 hours)
CL Item
2.75 hours (2.75 hours)
CL Item
3 hours (3 hours)
CL Item
4 hours (4 hours)
CL Item
6 hours (6 hours)
CL Item
8 hours (8 hours)
CL Item
10 hours (10 hours)
CL Item
12 hours (12 hours)
CL Item
14 hours (14 hours)
CL Item
24 hours (24 hours)
CL Item
48 hours (48 hours)
CL Item
72 hours (72 hours)
Actual time of blood sample collection for pharmacokinetics analysis
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Actual date/time of blood sample collection for pharmacokinetics analysis
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial