ID

33726

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 contains information about the blood sampling for lamotrigine or pharmakokinetics and metabolites. It should be filled out at each treatment period. 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 (4)
  1. 03.12.18 03.12.18 -
  2. 19.12.18 19.12.18 -
  3. 19.12.18 19.12.18 -
  4. 21.12.18 21.12.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

21. Dezember 2018

DOI

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

Englisch

Blood Sampling for Lamotrigine or PK and Metabolites

1 Formulare  
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
Dose Time
Beschreibung

transcribed from Drug Administration form

Datentyp

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Transcribed from Drug Administration form of CRF by
Beschreibung

Data Transcription, Clinical Staff Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
UMLS CUI [1,3]
C0871685
UMLS CUI [1,4]
C4554264
Study Visit
Beschreibung

Study Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Lamotrigine or Pharmacokinetics and Metabolites
Beschreibung

Lamotrigine or Pharmacokinetics and Metabolites

Datentyp

text

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0870883
UMLS CUI [2]
C0064636
Blood Sample for PK and metabolites or Lamotrigine
Beschreibung

Blood Sample for PK and metabolites or Lamotrigine

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031327
UMLS CUI-3
C0870883
UMLS CUI-4
C0064636
Study Day
Beschreibung

Study Day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Protocol Time
Beschreibung

Protocol Time

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

Time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Time Deviation
Beschreibung

e.g. +2 min Only record time deviation and code if there has been a protocol deviation. For PK sampling, a protocol deviation is defined as: 0-4 hrs post dose = 10 mins, 4-24 hrs post dose = 15 min

Datentyp

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1705236
Reason for Deviation
Beschreibung

enter one code only: Only record time deviation and code if there has been a protocol deviation. For PK sampling, a protocol deviation is defined as: 0-4 hrs post dose = 10 mins, , 4-24 hrs post dose = 15 min

Datentyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1705236
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Sample Number
Beschreibung

Pre Dose: Sample Nr. 101 0h30 post dose: Sample Nr. 102 1h00 post dose: Sample Nr. 103 1h30 post dose: Sample Nr. 104 2h00 post dose: Sample Nr. 105 4h00 post dose: Sample Nr. 106 6h00 post dose: Sample Nr. 107 12h30 post dose: Sample Nr. 108 24h00 post dose: Sample Nr. 109 48h00 post dose: Sample Nr. 110 72h00 post dose: Sample Nr. 111 120h00 post dose: Sample Nr. 112 144h00 post dose: Sample Nr. 113 216h00 post dose: Sample Nr. 114

Datentyp

text

Alias
UMLS CUI [1]
C1299222
PK sample type number
Beschreibung

PK sample type number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C1299222
Clinical Staff Initials
Beschreibung

Clinical Staff Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
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Ähnliche Modelle

Blood Sampling for Lamotrigine or PK and Metabolites

1 Formulare
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])
Dose Time
Item
Dose Time
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Data Transcription, Clinical Staff Initials
Item
Transcribed from Drug Administration form of CRF by
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
C0871685 (UMLS CUI [1,3])
C4554264 (UMLS CUI [1,4])
Item
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study Visit
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
Lamotrigine or Pharmacokinetics and Metabolites
text
C0031327 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
C0064636 (UMLS CUI [2])
Lamotrigine or Pharmacokinetics and Metabolites
Code List
Lamotrigine or Pharmacokinetics and Metabolites
CL Item
Lamotrigine (Lamotrigine)
CL Item
Pharmacokinetics and Metabolites (Pharmacokinetics and Metabolites)
Item Group
Blood Sample for PK and metabolites or Lamotrigine
C0005834 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
C0870883 (UMLS CUI-3)
C0064636 (UMLS CUI-4)
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)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
10 (8)
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
0h30 post dose (0h30 post dose)
CL Item
1h00 post dose (1h00 post dose)
CL Item
1h30 post dose (1h30 post dose)
CL Item
2h00 post dose (2h00 post dose)
CL Item
4h00 post dose (4h00 post dose)
CL Item
6h00 post dose (6h00 post dose)
CL Item
12h00 post dose (12h00 post dose)
CL Item
24h00 post dose (24h00 post dose)
CL Item
48h00 post dose (48h00 post dose)
CL Item
72h00 post dose (72h00 post dose)
CL Item
120h00 post dose (120h00 post dose)
CL Item
144h00 post dose (144h00 post dose)
CL Item
216h00 post dose (216h00 post dose)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Time Deviation
Item
Time Deviation
text
C0040223 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
Item
Reason for Deviation
integer
C0392360 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
Reason for Deviation
Code List
Reason for Deviation
CL Item
Slow/blocked cannula (1)
CL Item
poor veins/difficult venepuncture (2)
CL Item
subject not in attendance (3)
CL Item
Other (enter comment) (4)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
101 (101)
CL Item
102 (102)
CL Item
103 (103)
CL Item
104 (104)
CL Item
105 (105)
CL Item
106 (106)
CL Item
107 (107)
CL Item
108 (108)
CL Item
109 (109)
CL Item
110 (110)
CL Item
111 (111)
CL Item
112 (112)
CL Item
113 (113)
CL Item
114 (114)
Item
PK sample type number
integer
C0201734 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
PK sample type number
Code List
PK sample type number
CL Item
1 (PK and metabolites) (1)
CL Item
2 (Lamotrigine) (2)
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
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