ID
33258
Beschreibung
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. 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
Stichworte
Versionen (3)
- 03.12.18 03.12.18 -
- 11.12.18 11.12.18 -
- 23.01.19 23.01.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
3. Dezember 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold
12-Lead ECG Form
- StudyEvent: ODM
Beschreibung
12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Study Day
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826182
Beschreibung
Protocol Time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Actual Time
Datentyp
time
Alias
- UMLS CUI [1]
- C0040223
Beschreibung
RR Value
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0489636
Beschreibung
Result of ECG
Datentyp
text
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
Comments Indicator
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1522602
Beschreibung
Comments
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Clinical Staff Initials
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
Beschreibung
Pre-dose mean
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0439565
Beschreibung
RR Value
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0489636
Beschreibung
Comments Indicator
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1522602
Beschreibung
Comments
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Clinical Staff Initials
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
Beschreibung
Conclusion
Alias
- UMLS CUI-1
- C1707478
Ähnliche Modelle
12-Lead ECG Form
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C1522602 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])
C1522602 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])