ID
34693
Descripción
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
Palabras clave
Versiones (1)
- 23/1/19 23/1/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
23 de enero de 2019
DOI
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Licencia
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
Descripción
Unscheduled 12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C3854240
Descripción
Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
Actual Time
Tipo de datos
time
Alias
- UMLS CUI [1]
- C0040223
Descripción
Reason for Unscheduled Assessment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C3854240
- UMLS CUI [1,3]
- C0392360
Descripción
Comment
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0947611
Descripción
Comment Key
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1706198
Descripción
Clinical Staff Initials
Tipo de datos
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)
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C0392360 (UMLS CUI [1,3])
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Sin comentarios