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
Mots-clés
Versions (3)
- 03/12/2018 03/12/2018 -
- 11/12/2018 11/12/2018 -
- 23/01/2019 23/01/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
23 janvier 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
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
Type de données
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.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Description
Date
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Does not apply to the pre dose mean
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
RR Value
Type de données
integer
Unités de mesure
- 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
Type de données
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Comment Key
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1706198
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Clinical Staff Initials
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
Similar models
12-Lead ECG Form
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])