ID

38343

Beschreibung

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the Investigational Product - IV Dosing and the Randomisation form. It has to be filled in for Day 1 and Week 2.

Link

https://clinicaltrials.gov/ct2/show/NCT00833989

Stichworte

Versionen (2)
  1. 25.09.19 25.09.19 -
  2. 11.10.19 11.10.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. Oktober 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989

Englisch

Investigational Product Dosing, Randomisation

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Type
Beschreibung

Visit Type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Date of visit
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Randomisation
Beschreibung

Randomisation

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

If you tick yes, please fill in the Number and the Date of Randomisation in the following items.

Datentyp

text

Alias
UMLS CUI [1]
C0034656
Randomisation number
Beschreibung

Randomisation number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Investigational Product - IV Dosing
Beschreibung

Investigational Product - IV Dosing

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
Start Date of investigational Product
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Start Time of investigational Product
Beschreibung

00:00-23:59 Time is optional

Datentyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0304229
Stop Date of investigational Product
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Stop Time of investigational Product
Beschreibung

00:00-23:59 Time is optional

Datentyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0304229
Investigational product container number
Beschreibung

Investigational product container number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Was dose interrupted?
Beschreibung

If you tick yes, please select appropriate reason in the following item.

Datentyp

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1512900
Reason for dose interruption
Beschreibung

Reason for dose interruption

Datentyp

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1512900
UMLS CUI [1,3]
C0566251
If other reason for dose interruption, please specify
Beschreibung

Other reason for dose interruption, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1512900
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0566251
UMLS CUI [1,5]
C2348235
Total volume of infusion
Beschreibung

Total volume of infusion

Datentyp

float

Maßeinheiten
  • ml
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2700258
ml
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Ähnliche Modelle

Investigational Product Dosing, Randomisation

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Day 1 (1)
CL Item
Week 2 (2)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Item
Was the subject able to be randomised?
text
C0034656 (UMLS CUI [1])
Randomisation
Code List
Was the subject able to be randomised?
CL Item
Yes (Y)
CL Item
No (N)
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Investigational Product - IV Dosing
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Start Date
Item
Start Date of investigational Product
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Start Time
Item
Start Time of investigational Product
time
C1301880 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date of investigational Product
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Time
Item
Stop Time of investigational Product
time
C1522314 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product container number
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Was dose interrupted?
text
C0178602 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Dose interruption
Code List
Was dose interrupted?
CL Item
No (N)
CL Item
Yes (Y)
Item
Reason for dose interruption
integer
C0178602 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Dose interruption
Code List
Reason for dose interruption
CL Item
Adverse event (1)
CL Item
Dosing Error (2)
CL Item
Subject non-compliance (3)
CL Item
Mechanical problem (4)
CL Item
Other (5)
Other reason for dose interruption, specification
Item
If other reason for dose interruption, please specify
text
C0178602 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Total volume of infusion
Item
Total volume of infusion
float
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
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