ID
34692
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 is for documentation of the ECG. It should be filled out at each study visit. 3 measurements will be taken Pre dose on Day 1, the baseline will be considered the mean of the 3 measurements on day 1. 1 measurement will be taken post dose on day 2 and 3. Unscheduled ECGs should be documented in this form whenever they are performed during 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)
- 12/3/18 12/3/18 -
- 12/11/18 12/11/18 -
- 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
12-Lead ECG Form
- StudyEvent: ODM
Description
12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Description
Study Day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
3 measurements will be taken Pre dose on Day 1, the baseline will be considered the mean of the 3 measurements on day 1. 1 measurement will be taken post dose on day 2 and 3.
Data type
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Does not apply to the pre dose mean
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
RR Value
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0489636
Description
NCS= not clinically significant CS = Clinically Significant. If an ECG is deemed clinically significant, complete the "ECG Abnormalities" page in the CRF Does not apply to the pre dose mean
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Comment Key
Data type
integer
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1706198
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Clinical Staff Initials
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
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12-Lead ECG Form
- StudyEvent: ODM
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