ID

33429

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 demographic informations about 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 (3)
  1. 12/8/18 12/8/18 -
  2. 12/8/18 12/8/18 -
  3. 12/25/18 12/25/18 -
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

English

Demographics

1 forms  
  1. StudyEvent: ODM
    1. Demographics
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
Date Information Collected
Description

Date Information Collected

Data type

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date Informed Consent signed by subject
Description

Screening part only

Data type

date

Alias
UMLS CUI [1]
C2985782
Date Generic consent form signed by subject
Description

Date Generic consent form signed by subject

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
Date Pharmacogenetic Consent signed by subject
Description

Date Pharmacogenetic Consent signed by subject

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Gender
Description

Gender

Data type

date

Alias
UMLS CUI [1]
C0079399
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Ethnicity
Description

Ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Body Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Scale Number
Description

Scale Number

Data type

integer

Alias
UMLS CUI [1,1]
C0175659
UMLS CUI [1,2]
C0237753
Height
Description

Height

Data type

float

Measurement units
  • m
Alias
UMLS CUI [1]
C0005890
m
Body Mass Index
Description

19-29.9kg/m^2

Data type

float

Measurement units
  • kg/m^2
Alias
UMLS CUI [1]
C1305855
kg/m^2
Is BMI within acceptable range?
Description

Acceptable Range: 19-29.9kg/m

Data type

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C1514721
UMLS CUI [1,3]
C1879533
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

Demographics

1 forms
  1. StudyEvent: ODM
    1. Demographics
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])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date Informed Consent signed by subject
Item
Date Informed Consent signed by subject
date
C2985782 (UMLS CUI [1])
Date Generic consent form signed by subject
Item
Date Generic consent form signed by subject
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
Date Pharmacogenetic Consent signed by subject
Item
Date Pharmacogenetic Consent signed by subject
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Gender
Item
Gender
date
C0079399 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (Hispanic or Latino)
CL Item
Not Hispanic or Latino (Not Hispanic or Latino)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
American Hispanic (American Hispanic)
CL Item
African American/African Heritage (African American/African Heritage)
CL Item
American Indian or Alaskan Native (American Indian or Alaskan Native)
CL Item
Native Hawaiian or Other Pacific Islander (Native Hawaiian or Other Pacific Islander)
CL Item
Arabic/North African (Arabic/North African)
CL Item
Black (Black)
CL Item
East & South East Asian (East & South East Asian)
CL Item
Japanese (Japanese)
CL Item
South Asian (South Asian)
CL Item
White/Caucasian (White/Caucasian)
CL Item
Mixed race (Mixed race)
CL Item
Other (Other)
CL Item
Asian – Central/South Asian Heritage (Asian – Central/South Asian Heritage)
CL Item
Asian – East Asian Heritage (Asian – East Asian Heritage)
CL Item
Asian – Japanese Heritage (Asian – Japanese Heritage)
CL Item
Asian – South East Asian Heritage (Asian – South East Asian Heritage)
CL Item
White – Arabic/North African Heritage (White – Arabic/North African Heritage)
CL Item
White – White/Caucasian/European Heritage (White – White/Caucasian/European Heritage)
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Scale Number
Item
Scale Number
integer
C0175659 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
BMI
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
BMI within Acceptable Range
Item
Is BMI within acceptable range?
boolean
C1305855 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
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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