ID

33433

Beschreibung

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains informations about the next of kin, as well as the general practicioner of the subject. It should be filled out at the screening visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Stichworte

Versionen (4)
  1. 01.12.18 01.12.18 -
  2. 08.12.18 08.12.18 -
  3. 08.12.18 08.12.18 -
  4. 18.12.18 18.12.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

8. Dezember 2018

DOI

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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Englisch

Details of Next of Kin and GP

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Beschreibung

Date Information Collected

Datentyp

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Details of Next of Kin
Beschreibung

Details of Next of Kin

Alias
UMLS CUI-1
C0421492
Name
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0421492
Address
Beschreibung

Address

Datentyp

text

Alias
UMLS CUI [1,1]
C0421492
UMLS CUI [1,2]
C1442065
Post Code
Beschreibung

Post Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0421492
UMLS CUI [1,2]
C1442065
UMLS CUI [1,3]
C3166855
Telephone Number
Beschreibung

Telephone Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1515258
UMLS CUI [1,2]
C0421492
Relationship
Beschreibung

Relationship

Datentyp

text

Alias
UMLS CUI [1,1]
C0015608
UMLS CUI [1,2]
C0421492
Details of General Practitioner
Beschreibung

Details of General Practitioner

Alias
UMLS CUI-1
C0017319
Name of Doctor
Beschreibung

Name of Doctor

Datentyp

text

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0027365
Address
Beschreibung

Address

Datentyp

text

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C1442065
Telephone Number
Beschreibung

Telephone Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C1515258
Fax Number
Beschreibung

Fax Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C1549619
Permission to Contact GP
Beschreibung

If no, exclude

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C0521104
UMLS CUI [1,3]
C0337611
GP letter sent
Beschreibung

GP letter sent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C1519246
Date GP letter sent
Beschreibung

Date GP letter sent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C1519246
UMLS CUI [1,4]
C0011008
GP response to letter received?
Beschreibung

GP response to letter received?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C2911692
UMLS CUI [1,4]
C1551046
Conclusion
Beschreibung

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschreibung

Staff initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
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Ähnliche Modelle

Details of Next of Kin and GP

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Details of Next of Kin
C0421492 (UMLS CUI-1)
Name
Item
Name
text
C0027365 (UMLS CUI [1,1])
C0421492 (UMLS CUI [1,2])
Address
Item
Address
text
C0421492 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Post Code
Item
Post Code
text
C0421492 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
C3166855 (UMLS CUI [1,3])
Telephone Number
Item
Telephone Number
text
C1515258 (UMLS CUI [1,1])
C0421492 (UMLS CUI [1,2])
Relationship
Item
Relationship
text
C0015608 (UMLS CUI [1,1])
C0421492 (UMLS CUI [1,2])
Item Group
Details of General Practitioner
C0017319 (UMLS CUI-1)
Name of Doctor
Item
Name of Doctor
text
C0031831 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Address
Item
Address
text
C0017319 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Telephone Number
Item
Telephone Number
text
C0017319 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Fax Number
Item
Fax Number
text
C0017319 (UMLS CUI [1,1])
C1549619 (UMLS CUI [1,2])
Permission to Contact GP
Item
Permission to Contact GP
boolean
C0017319 (UMLS CUI [1,1])
C0521104 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
GP letter sent
Item
GP letter sent
boolean
C0017319 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C1519246 (UMLS CUI [1,3])
Date GP letter sent
Item
Date GP letter sent
boolean
C0017319 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C1519246 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
GP response to letter received?
Item
GP response to letter received?
boolean
C0017319 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C2911692 (UMLS CUI [1,3])
C1551046 (UMLS CUI [1,4])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
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