ID

34635

Beskrivning

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 contains informations about additional clinical laboratory safety tests. It should be filled out at each treatment period on admission, and on day 3, 48h00 post-dose. 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

Nyckelord

Versioner (2)
  1. 2018-12-03 2018-12-03 -
  2. 2019-01-21 2019-01-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21 januari 2019

DOI

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Licens

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

Engelsk

Clinical Laboratory Safety Tests 2

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beskrivning

Subject Screening No.

Datatyp

integer

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

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Beskrivning

Date Information Collected

Datatyp

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Study Visit
Beskrivning

Study Visit

Datatyp

text

Alias
UMLS CUI [1]
C0545082
Treatment Period
Beskrivning

Treatment Period

Datatyp

text

Alias
UMLS CUI [1]
C2347804
Blood Samples
Beskrivning

Blood Samples

Alias
UMLS CUI-1
C0178913
Has the subject fasted?
Beskrivning

Subject Fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
Time Blood Samples Taken
Beskrivning

Time Blood Samples Taken

Datatyp

time

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0040223
Clinical Chemistry
Beskrivning

Clinical Chemistry

Datatyp

text

Alias
UMLS CUI [1]
C0008000
Haematology
Beskrivning

Haematology

Datatyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0022885
Clinical Staff Initials
Beskrivning

Clinical Staff Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Urine Sample
Beskrivning

Urine Sample

Alias
UMLS CUI-1
C0200354
Time Urine Samples Taken
Beskrivning

Time Urine Samples Taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0040223
Urinalysis
Beskrivning

Urinalysis

Datatyp

text

Alias
UMLS CUI [1]
C0042014
Drugs of Abuse & Alcohol Screen
Beskrivning

Drug and Alcohol Abuse

Datatyp

text

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0085762
UMLS CUI [3]
C0202274
Clinical Staff Initials
Beskrivning

Clinical Staff Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Result Significance
Beskrivning

Result Significance

Alias
UMLS CUI-1
C2826633
Are any of the out of range results clinically significant?
Beskrivning

Results Clinically Significant

Datatyp

boolean

Alias
UMLS CUI [1]
C2826633
If results are clinically significant, comment below.
Beskrivning

Result Comments

Datatyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0947611
Physician's Initials
Beskrivning

Physician's Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
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Similar models

Clinical Laboratory Safety Tests 2

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study Visit
CL Item
Admission (Admission)
CL Item
Day3, 48h post dose (Day3, 48h post dose)
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
Blood Samples
C0178913 (UMLS CUI-1)
Subject Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Time Blood Samples Taken
Item
Time Blood Samples Taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Clinical Chemistry
Item
Clinical Chemistry
text
C0008000 (UMLS CUI [1])
Haematology
Item
Haematology
text
C0474523 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Urine Sample
C0200354 (UMLS CUI-1)
Time Urine Samples Taken
Item
Time Urine Samples Taken
time
C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Urinalysis
Item
Urinalysis
text
C0042014 (UMLS CUI [1])
Drug and Alcohol Abuse
Item
Drugs of Abuse & Alcohol Screen
text
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
C0202274 (UMLS CUI [3])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Result Significance
C2826633 (UMLS CUI-1)
Results Clinically Significant
Item
Are any of the out of range results clinically significant?
boolean
C2826633 (UMLS CUI [1])
Result Comments
Item
If results are clinically significant, comment below.
text
C1274040 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
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