ID

33426

Description

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 information 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

Keywords

Versions (2)
  1. 12/1/18 12/1/18 -
  2. 12/8/18 12/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 8, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

English

Subject Identification

1 forms  
  1. StudyEvent: ODM
    1. Subject Identification
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Description

Subject Screening No.

Data type

integer

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

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Part
Description

Part

Data type

integer

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Subject Identification
Description

Subject Identification

Alias
UMLS CUI-1
C1269815
Date Information Collected
Description

Date Information Collected

Data type

date

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

Surname

Data type

text

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

Forename(s)

Data type

text

Alias
UMLS CUI [1]
C1443235
Current Address
Description

Current Address

Data type

text

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

Postal Code of Current Address

Data type

text

Alias
UMLS CUI [1]
C0421454
Telephone Number
Description

Telephone Number

Data type

text

Alias
UMLS CUI [1]
C1515258
Permanent Address
Description

If different from above

Data type

text

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

If different from above

Data type

text

Alias
UMLS CUI [1]
C0421454
Method of Identification
Description

Method of Identification

Data type

text

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

Other Method of Identification

Data type

text

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

Employment Status

Alias
UMLS CUI-1
C0242271
Occupation
Description

Occupation

Data type

text

Alias
UMLS CUI [1]
C0028811
Medical Student?
Description

Medical Student

Data type

boolean

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

To be filled in if the subject is a medical student

Data type

text

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

Dean's letter sent

Data type

text

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

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Description

Staff initials

Data type

text

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

Subject Identification

1 forms
  1. StudyEvent: ODM
    1. Subject Identification
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Part
Item
Part
integer
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Cohort
Item
Cohort
integer
C0599755 (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])
Method of Identification
Code List
Method of Identification
CL Item
Passport (Passport)
CL Item
Driving Licence (Driving Licence)
CL Item
Other (Other)
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])
Dean's letter sent
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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