ID
33431
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 dietary status and physical activity. It should be filled out at the screening visit. Dietary Restricions: Subjects not to consume the following foodstuffs for five days prior to and including each dosing day:- - Grapfruit, Grapefruit juice and grapefruit containing products - Quinine – containing products - Broccoli - Brussel sprouts - Watercress - Cabbage (incl. Coleslaw) - Charcoal broiled beef Subjects will refrain from consuming caffeinated beverages for 48 hours prior to and including each dosing day Subjects must refrain from strenuous exercise for 48 hours before the screening medical examination and for the entire duration of the study 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)
- 12/1/18 12/1/18 -
- 12/8/18 12/8/18 -
- 12/18/18 12/18/18 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
December 8, 2018
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Effect of Lamictal on Resting Motor Threshold Study-ID 107434
Dietary Status and Physical Activity
- StudyEvent: ODM
Description
Dietary Status and Physical Activity
Alias
- UMLS CUI-1
- C0392209
- UMLS CUI-2
- C0026606
Description
If Yes, exclude
Data type
boolean
Alias
- UMLS CUI [1]
- C0042441
- UMLS CUI [2]
- C2987738
Description
If yes, detail below
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0425422
- UMLS CUI [1,2]
- C0205476
Description
If subject has any medical dietary restrictions
Data type
text
Alias
- UMLS CUI [1,1]
- C0425422
- UMLS CUI [1,2]
- C0205476
- UMLS CUI [1,3]
- C2348235
Description
Subject Caffeine Consumption
Data type
boolean
Alias
- UMLS CUI [1]
- C0948365
Description
If the subject consumes caffeine UPPER LIMIT OF CAFFEINE IS 6 CUPS PER DAY
Data type
integer
Measurement units
- cups/day
Alias
- UMLS CUI [1,1]
- C0948365
- UMLS CUI [1,2]
- C2164136
Description
If Yes, complete below
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0679823
- UMLS CUI [1,2]
- C0015259
Description
If subject participates in any exercise
Data type
text
Alias
- UMLS CUI [1,1]
- C0015259
- UMLS CUI [1,2]
- C0332307
Description
No. of Exercise Sessions per Week
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015259
- UMLS CUI [1,2]
- C0585296
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
Similar models
Dietary Status and Physical Activity
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0026606 (UMLS CUI-2)
C2987738 (UMLS CUI [2])
C0205476 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C2164136 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0585296 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])