ID

34692

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. 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

Stichworte

Versionen (3)
  1. 03.12.18 03.12.18 -
  2. 11.12.18 11.12.18 -
  3. 23.01.19 23.01.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

23. Januar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Englisch

12-Lead ECG Form

1 Formulare  
  1. StudyEvent: ODM
    1. 12-Lead ECG Form
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Treatment Period
Beschreibung

Treatment Period

Datentyp

text

Alias
UMLS CUI [1]
C2347804
12-Lead Electrocardiogram
Beschreibung

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Study Day
Beschreibung

Study Day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Protocol Time
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2348563
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beschreibung

Does not apply to the pre dose mean

Datentyp

time

Alias
UMLS CUI [1]
C0040223
RR Value
Beschreibung

RR Value

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0489636
msec
Result of ECG
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
Comment Key
Beschreibung

Comment Key

Datentyp

integer

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1706198
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Clinical Staff Initials
Beschreibung

Clinical Staff Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
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Ähnliche Modelle

12-Lead ECG Form

1 Formulare
  1. StudyEvent: ODM
    1. 12-Lead ECG Form
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Item
Treatment Period
text
C2347804 (UMLS CUI [1])
Treatment Period
Code List
Treatment Period
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
CL Item
Treatment Period 3 (Treatment Period 3)
Item Group
12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Protocol Time
text
C0040223 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Protocol Time
Code List
Protocol Time
CL Item
Pre dose (Pre dose)
CL Item
Pre-dose mean (Pre-dose mean)
CL Item
24h00 post dose (24h00 post dose)
CL Item
48h00 post dose (48h00 post dose)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
RR Value
Item
RR Value
integer
C0489636 (UMLS CUI [1])
Item
Result of ECG
integer
C0438154 (UMLS CUI [1])
Result of ECG
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal-NCS (2)
CL Item
Abnormal-CS (3)
CL Item
No Result (not available) (4)
Item
Comment Key
integer
C0947611 (UMLS CUI [1,1])
C1706198 (UMLS CUI [1,2])
Comments Indicator
Code List
Comment Key
CL Item
Not done due to adverse event (describe) (1)
CL Item
Late due to late running of previous assessment (2)
CL Item
Subject not in attendance (confirm time delay) (3)
CL Item
Late due to technical problems (confirm time delay) (4)
CL Item
Other (describe) (5)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
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