ID
34725
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 information about any concomitant medication the subject used during the study. It should be filled out at screening (, transcribed to the main form) and updated every 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)
- 12/1/18 12/1/18 -
- 12/9/18 12/9/18 -
- 1/21/19 1/21/19 -
- 1/25/19 1/25/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
January 25, 2019
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
Concomitant Medication
- StudyEvent: ODM
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
If yes, record details below. Paracetamol for mild analgesia may be permitted This item only applies to the screening visit.
Data type
text
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C3166216
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0013231
- UMLS CUI [3,1]
- C0332257
- UMLS CUI [3,2]
- C0042890
- UMLS CUI [4,1]
- C0332257
- UMLS CUI [4,2]
- C1360419
- UMLS CUI [5,1]
- C0332257
- UMLS CUI [5,2]
- C0003138
Description
Only applicable for the source document.
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Only applicable for the source document.
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
Description
Concomitant Medication Details
Alias
- UMLS CUI-1
- C2347852
Description
Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2347852
Description
If known
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Description
Generic/Brand
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
Description
Dose
Data type
text
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
Description
Units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Description
Route
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Description
Frequency
Data type
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Description
Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
Description
Medication Ongoing
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
Description
Only applicable for the screening document.
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C0031831
Description
Only applicable for the source document.
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
- UMLS CUI [1,3]
- C4554264
Similar models
Concomitant Medication
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C3166216 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0332257 (UMLS CUI [3,1])
C0042890 (UMLS CUI [3,2])
C0332257 (UMLS CUI [4,1])
C1360419 (UMLS CUI [4,2])
C0332257 (UMLS CUI [5,1])
C0003138 (UMLS CUI [5,2])
C1552089 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])
C4554264 (UMLS CUI [1,3])
No comments