ID

33432

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 informations about the subjects alcohol and tobacco use. 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 (4)
  1. 12/1/18 12/1/18 -
  2. 12/8/18 12/8/18 -
  3. 12/8/18 12/8/18 -
  4. 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 Study-ID 107434

English

Alcohol and Tobacco Use

1 forms  
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
Tobacco Use
Description

Tobacco Use

Alias
UMLS CUI-1
C0040329
Tobacco/Nicotine containing products
Description

Tobacco/Nicotine containing products

Data type

text

Alias
UMLS CUI [1]
C0543414
Date Stopped Smoking
Description

If former smoker

Data type

date

Alias
UMLS CUI [1,1]
C0425310
UMLS CUI [1,2]
C0806020
No. of cigarettes smoked per day
Description

Exclude if current smoker smokes more than 10 cigarettes a day

Data type

integer

Alias
UMLS CUI [1]
C1608325
No. of pipes smoked per day
Description

If current smoker

Data type

integer

Alias
UMLS CUI [1,1]
C0337665
UMLS CUI [1,2]
C1608325
Quantity of tobacco per day
Description

If current smoker

Data type

integer

Measurement units
  • g
Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C1265611
g
Other
Description

If current smoker

Data type

text

Alias
UMLS CUI [1]
C0205394
Alcohol consumption
Description

Alcohol consumption

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Description

Subject alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
Number of Alcohol Units Consumed per Week
Description

EXCLUDE IF ALCOHOL CONSUMPTION IS GREATER THAN 21 UNITS PER WEEK OR AN AVERAGE DAILY INTAKE IS GREATER THAN 3 UNITS Key 1 unit = 125ml glass of wine = 25ml of spirits = 220ml of beer

Data type

integer

Measurement units
  • Units/week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
Units/week
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Physician's Initials
Description

Physician's Initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
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

Alcohol and Tobacco Use

1 forms
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
Tobacco Use
C0040329 (UMLS CUI-1)
Item
Tobacco/Nicotine containing products
text
C0543414 (UMLS CUI [1])
Tobacco/Nicotine containing products
Code List
Tobacco/Nicotine containing products
CL Item
Never smoked/never consumed nicotine containing products (Never smoked/never consumed nicotine containing products)
CL Item
Former smoker/Former consumer (Former smoker/Former consumer)
CL Item
Current smoker (Current smoker)
Date Stopped Smoking
Item
Date Stopped Smoking
date
C0425310 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
No. of cigarettes smoked per day
Item
No. of cigarettes smoked per day
integer
C1608325 (UMLS CUI [1])
No. of pipes smoked per day
Item
No. of pipes smoked per day
integer
C0337665 (UMLS CUI [1,1])
C1608325 (UMLS CUI [1,2])
Quantity of tobacco per day
Item
Quantity of tobacco per day
integer
C0543414 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Other
Item
Other
text
C0205394 (UMLS CUI [1])
Item Group
Alcohol consumption
C0001948 (UMLS CUI-1)
Subject alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Number of Alcohol Units Consumed per Week
Item
Number of Alcohol Units Consumed per Week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
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