ID

33048

Beschreibung

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

Link

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

Stichworte

Versionen (3)
  1. 18.11.18 18.11.18 -
  2. 25.11.18 25.11.18 -
  3. 25.11.18 25.11.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

25. November 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784

Englisch

Randomisation Number, Investigational Products, Pharmacokinetics Blood

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beschreibung

Visit Type

Datentyp

text

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

Randomisation Number (Only Visit 1)

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

Subject's randomisation

Datentyp

boolean

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

Randomisation number

Datentyp

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
Beschreibung

Date of randomisation

Datentyp

date

Alias
UMLS CUI [1]
C0034656
Investigational Product
Beschreibung

Investigational Product

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

Date/time of dose

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1264639
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

Receivement of the correct treatment

Datentyp

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)
Beschreibung

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

Datentyp

text

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

Dosing Date and Time

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

Dosing date/time

Datentyp

datetime

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

Pharmacokinetics Blood

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

Planned relative time of blood sample collection for pharmacokinetics analysis

Datentyp

text

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

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

Datentyp

time

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

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

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005834
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Ähnliche Modelle

Randomisation Number, Investigational Products, Pharmacokinetics Blood

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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