ID

33201

Beschrijving

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 basic informations 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

Trefwoorden

  1. 01-12-18 01-12-18 -
  2. 08-12-18 08-12-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

1 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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Effect of Lamictal on Resting Motor Threshold

Subject Identification

  1. StudyEvent: ODM
    1. Subject Identification
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschrijving

Subject Screening No.

Datatype

integer

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

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Identification
Beschrijving

Subject Identification

Alias
UMLS CUI-1
C1269815
Date Information Collected
Beschrijving

Date Information Collected

Datatype

date

Alias
UMLS CUI [1,1]
C0010995
UMLS CUI [1,2]
C0011008
Surname
Beschrijving

Surname

Datatype

text

Alias
UMLS CUI [1]
C0421448
Forename(s)
Beschrijving

Forename(s)

Datatype

text

Alias
UMLS CUI [1]
C1443235
Current Address
Beschrijving

Current Address

Datatype

text

Alias
UMLS CUI [1]
C0421449
Postal Code of Current Address
Beschrijving

Postal Code of Current Address

Datatype

text

Alias
UMLS CUI [1]
C0421454
Telephone Number
Beschrijving

Telephone Number

Datatype

text

Alias
UMLS CUI [1]
C1515258
Permanent Address
Beschrijving

If different from above

Datatype

text

Alias
UMLS CUI [1]
C0421449
Permanent Address Postal Code
Beschrijving

If different from above

Datatype

text

Alias
UMLS CUI [1]
C0421454
Method of Identification
Beschrijving

Method of Identification

Datatype

text

Alias
UMLS CUI [1]
C1269815
Other Method of Identification
Beschrijving

Other Method of Identification

Datatype

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C0205394
Employment Status
Beschrijving

Employment Status

Alias
UMLS CUI-1
C0242271
Occupation
Beschrijving

Occupation

Datatype

text

Alias
UMLS CUI [1]
C0028811
Medical Student?
Beschrijving

Medical Student

Datatype

boolean

Alias
UMLS CUI [1]
C0038495
Medical School of subject
Beschrijving

To be filled in if the subject is a medical student

Datatype

text

Alias
UMLS CUI [1]
C0036378
Dean's letter sent
Beschrijving

Dean's letter sent

Datatype

text

Alias
UMLS CUI [1,1]
C0401902
UMLS CUI [1,2]
C1096774
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschrijving

Staff initials

Datatype

text

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

Similar models

Subject Identification

  1. StudyEvent: ODM
    1. Subject Identification
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Item Group
Subject Identification
C1269815 (UMLS CUI-1)
Date Information Collected
Item
Date Information Collected
date
C0010995 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Surname
Item
Surname
text
C0421448 (UMLS CUI [1])
Forename(s)
Item
Forename(s)
text
C1443235 (UMLS CUI [1])
Current Address
Item
Current Address
text
C0421449 (UMLS CUI [1])
Postal Code of Current Address
Item
Postal Code of Current Address
text
C0421454 (UMLS CUI [1])
Telephone Number
Item
Telephone Number
text
C1515258 (UMLS CUI [1])
Permanent Address
Item
Permanent Address
text
C0421449 (UMLS CUI [1])
Permanent Address Postal Code
Item
Permanent Address Postal Code
text
C0421454 (UMLS CUI [1])
Item
Method of Identification
text
C1269815 (UMLS CUI [1])
Code List
Method of Identification
CL Item
Passport (Passport)
CL Item
Driving Licence (Driving Licence)
Other Method of Identification
Item
Other Method of Identification
text
C1269815 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Employment Status
C0242271 (UMLS CUI-1)
Occupation
Item
Occupation
text
C0028811 (UMLS CUI [1])
Medical Student
Item
Medical Student?
boolean
C0038495 (UMLS CUI [1])
Medical School
Item
Medical School of subject
text
C0036378 (UMLS CUI [1])
Item
Dean's letter sent
text
C0401902 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
Code List
Dean's letter sent
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NREQ (NREQ)
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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