ID
34693
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 Unscheduled ECGs should be documented in this form whenever they are performed during the study. If an ECG is deemed Abnormal, clinically significant, complete the “ECG Abnormalities” page in the CRF. 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 (1)
- 1/23/19 1/23/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 23, 2019
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
Unscheduled 12-Lead ECG Form
- StudyEvent: ODM
Description
Unscheduled 12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C3854240
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Actual Time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
Reason for Unscheduled Assessment
Data type
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C3854240
- UMLS CUI [1,3]
- C0392360
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Comment Key
Data type
integer
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1706198
Description
Clinical Staff Initials
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
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Unscheduled 12-Lead ECG Form
- StudyEvent: ODM
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C3854240 (UMLS CUI-2)
C3854240 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1552089 (UMLS CUI [1,2])
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