ID

36193

Beskrivning

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Nyckelord

Versioner (1)
  1. 2019-04-22 2019-04-22 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

22 april 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

Engelsk

Period 2 Day 43

1 Formulär  
  1. StudyEvent: ODM
    1. Period 2 Day 43
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Drug Screen
Beskrivning

Drug Screen

Alias
UMLS CUI-1
C0373483
Date and time of sample taken
Beskrivning

Drug screen, Sampling, Date in time, Time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Cocaine
Beskrivning

Drug screen, Cocaine

Datatyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0009170
Amphetamines
Beskrivning

Drug screen, Amphetamines

Datatyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0002667
Benzodiazepines
Beskrivning

Drug screen, Benzodiazepines

Datatyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0005064
Cannabinoids
Beskrivning

Drug screen, Cannabinoids

Datatyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0006864
Opiates
Beskrivning

Drug screen, Opiates

Datatyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0376196
Barbiturates
Beskrivning

Drug screen, Barbiturates

Datatyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0004745
Alcohol Breath Test
Beskrivning

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Date sample taken
Beskrivning

Ethanol measurement, breath, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0011008
Results
Beskrivning

Ethanol measurement, breath, Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
Pregnancy
Beskrivning

Pregnancy

Alias
UMLS CUI-1
C0032961
Was a pregnancy test performed?
Beskrivning

Pregnancy Tests

Datatyp

text

Alias
UMLS CUI [1]
C0032976
Results
Beskrivning

Pregnancy Tests, Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beskrivning

Vital Signs Date

Datatyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Beskrivning

Vital Signs, Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Actual Time
Beskrivning

Vital Signs Time

Datatyp

text

Alias
UMLS CUI [1]
C2826762
Blood Pressure - Systolic
Beskrivning

Systolic Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure - Diastolic
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Beskrivning

Standing, Semi-Supine

Datatyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Electronically transferred laboratory data - Clinical Chemistry, Haematology
Beskrivning

Electronically transferred laboratory data - Clinical Chemistry, Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Date Sample Taken
Beskrivning

Chemistry, Clinical, Hematologic tests, Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beskrivning

Chemistry, Clinical, Hematologic tests, Sampling, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
12-Lead ECG
Beskrivning

12-Lead ECG

Alias
UMLS CUI-1
C0430456
No.
Beskrivning

12 lead ECG, Numbers

Datatyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beskrivning

12 lead ECG, Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Beskrivning

12 lead ECG, Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Start Time of ECG
Beskrivning

12 lead ECG, Start Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Beskrivning

12 lead ECG, Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Beskrivning

12 lead ECG, PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beskrivning

12 lead ECG, QRS complex duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beskrivning

12 lead ECG, QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beskrivning

12 lead ECG, QT corrected Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Beskrivning

12 lead ECG, Result

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Relative Time
Beskrivning

Experimental drug, Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date of Dose
Beskrivning

Experimental drug, Dosage, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Beskrivning

Experimental drug, Dosage, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Tillbaka till toppen

Similar models

Period 2 Day 43

1 Formulär
  1. StudyEvent: ODM
    1. Period 2 Day 43
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Drug Screen
C0373483 (UMLS CUI-1)
Drug screen, Sampling, Date in time, Time
Item
Date and time of sample taken
datetime
C0373483 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Cocaine
text
C0373483 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Cocaine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
text
C0373483 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
text
C0373483 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
text
C0373483 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
text
C0373483 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
text
C0373483 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
Ethanol measurement, breath, Date in time
Item
Date sample taken
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Results
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Ethanol measurement, breath, Result
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Pregnancy
C0032961 (UMLS CUI-1)
Item
Was a pregnancy test performed?
text
C0032976 (UMLS CUI [1])
Pregnancy Tests
Code List
Was a pregnancy test performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item
Results
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy Tests
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs Date
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Vital Signs, Relative time, Planned
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
Pre-dose (2)
CL Item
+2 hrs (3)
CL Item
+4 hrs (4)
CL Item
+6 hrs (5)
CL Item
+6 hrs (6)
CL Item
+8 hrs (7)
CL Item
+12 hrs (8)
CL Item
+12 hrs (9)
CL Item
+24 hrs (10)
CL Item
+24 hrs (11)
Vital Signs Time
Item
Actual Time
text
C2826762 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure - Diastolic
integer
C0428883 (UMLS CUI [1])
Vital Signs, Body Position
Item
Subject Position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Electronically transferred laboratory data - Clinical Chemistry, Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Chemistry, Clinical, Hematologic tests, Sampling, Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Chemistry, Clinical, Hematologic tests, Sampling, Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
No.
text
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
12 lead ECG, Numbers
Code List
No.
CL Item
ECG1 (1)
CL Item
ECG2 (2)
CL Item
ECG3 (3)
CL Item
ECG4 (4)
CL Item
ECG5 (5)
CL Item
ECG6 (6)
12 lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
12 lead ECG, Relative time, Planned
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
+ 2 hrs (2)
CL Item
+ 4 hrs (3)
CL Item
+ 8 hrs (4)
CL Item
+ 12 hrs (5)
CL Item
+ 24 hrs (6)
12 lead ECG, Start Time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
12 lead ECG, Heart rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG, QT corrected Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Planned Relative Time
text
C0304229 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Experimental drug, Relative time, Planned
Code List
Planned Relative Time
CL Item
Day 43 - AM (1)
CL Item
Day 43 - PM (2)
Experimental drug, Dosage, Date in time
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental drug, Dosage, Time
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Tillbaka till toppen 

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