ID

30336

Beschreibung

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Visit Documentation 6 Specification: Cohort 1-4 RD Day-3

Link

https://clinicaltrials.gov/ct2/show/NCT01036061

Stichworte

Versionen (1)
  1. 29.05.18 29.05.18 -
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GlaxoSmithKline

Hochgeladen am

29. Mai 2018

DOI

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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061

Englisch

Visit Documentation 6

1 Formulare  
  1. StudyEvent: ODM
    1. Visit Documentation 6
Date and Type of Visit
Beschreibung

Date and Type of Visit

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C3641100
UMLS CUI-3
C0008976
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Time of Visit
Beschreibung

Time of Visit

Datentyp

time

Alias
UMLS CUI [1]
C1320304
Cohort
Beschreibung

Cohort

Datentyp

integer

Alias
UMLS CUI [1]
C0599755
Type of Visit
Beschreibung

Please choose the type of visit/form you would like to answer, for example Cohort 1-4 SD Day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C3641100
UMLS CUI [1,2]
C0008976
ECG
Beschreibung

ECG

Alias
UMLS CUI-1
C1623258
Type of ECG
Beschreibung

Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) Cohort 1-4 RD Day 3: 12-lead-ECG

Datentyp

integer

Alias
UMLS CUI [1]
C1623258
Start Date ECG
Beschreibung

Start Date ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0808070
Start Time ECG
Beschreibung

Start Time ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1301880
Stop Date ECG
Beschreibung

Stop Date ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0806020
Stop Time ECG
Beschreibung

Stop Time ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
If Holter ECG, please select duration of ECG recording
Beschreibung

Duration of ECG recording

Datentyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0449238
Clinical Chemistry
Beschreibung

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Date and time sample taken
Beschreibung

Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Has the subject fasted?
Beschreibung

Fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Chemistry Analytes
Beschreibung

Please answer the following questions for each Clinical Chemistry Analyte

Datentyp

integer

Alias
UMLS CUI [1]
C0008000
Clinical Chemistry, type of result
Beschreibung

Type of result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
Clinical Chemistry Numeric Result (if Numeric Result)
Beschreibung

Clinical Chemistry Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2347373
Clinical Chemistry Character Result (if Character Result)
Beschreibung

Clinical Chemistry Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2350015
Questionnaires
Beschreibung

Questionnaires

Alias
UMLS CUI-1
C0034394
Simpson Angus Scale Score
Beschreibung

Please fill out 3h after dosing

Datentyp

integer

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0015371
UMLS CUI [1,3]
C0681889
The Barnes Akathisia Scale Score
Beschreibung

The Barnes Akathisia Scale Score

Datentyp

integer

Alias
UMLS CUI [1]
C3541345
Abnormal Involuntary Movement Scale Score
Beschreibung

Abnormal Involuntary Movement Scale Score

Datentyp

integer

Alias
UMLS CUI [1]
C0450978
Profile of Mood States
Beschreibung

Profile of Mood States

Datentyp

text

Alias
UMLS CUI [1]
C0451394
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Date of dose
Beschreibung

Date of dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
Time of dose
Beschreibung

Time of dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
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Ähnliche Modelle

Visit Documentation 6

1 Formulare
  1. StudyEvent: ODM
    1. Visit Documentation 6
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date and Type of Visit
C1320303 (UMLS CUI-1)
C3641100 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Time of Visit
Item
Time of Visit
time
C1320304 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Cohort 1 (1)
CL Item
Cohort 2 (2)
CL Item
Cohort 3 (3)
CL Item
Cohort 4 (4)
CL Item
PET (5)
Item
Type of Visit
integer
C3641100 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Type of Visit
Code List
Type of Visit
CL Item
Cohort 1-4 RD Day 3 (1)
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Type of ECG
integer
C1623258 (UMLS CUI [1])
Type of ECG
Code List
Type of ECG
CL Item
12 lead ECG (1)
CL Item
Holter ECG (2)
CL Item
Telemetry ECG (3)
Start Date ECG
Item
Start Date ECG
date
C1623258 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time ECG
Item
Start Time ECG
time
C1623258 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date ECG
Item
Stop Date ECG
date
C1623258 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time ECG
Item
Stop Time ECG
time
C1623258 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
If Holter ECG, please select duration of ECG recording
integer
C1623258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of ECG recording
Code List
If Holter ECG, please select duration of ECG recording
CL Item
0-24hrs (1)
CL Item
0-48hrs (2)
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item
Clinical Chemistry Analytes
integer
C0008000 (UMLS CUI [1])
Clinical Chemistry Analytes
Code List
Clinical Chemistry Analytes
CL Item
ALT (1)
C0201850 (UMLS CUI-1)
(Comment:en)
CL Item
AST (2)
C0201836 (UMLS CUI-1)
(Comment:en)
CL Item
Total Bilirubin (3)
C0201913 (UMLS CUI-1)
(Comment:en)
CL Item
Direct Bilirubin  (4)
C0201916 (UMLS CUI-1)
(Comment:en)
CL Item
Glucose (5)
C0337438 (UMLS CUI-1)
(Comment:en)
CL Item
GGT (6)
C0202035 (UMLS CUI-1)
(Comment:en)
CL Item
Total Protein  (7)
C0555903 (UMLS CUI-1)
(Comment:en)
CL Item
Albumin (8)
C0201838 (UMLS CUI-1)
(Comment:en)
CL Item
Potassium (9)
C0202194 (UMLS CUI-1)
(Comment:en)
CL Item
Sodium (10)
C0337443 (UMLS CUI-1)
(Comment:en)
CL Item
Chloride (11)
C0201952 (UMLS CUI-1)
(Comment:en)
CL Item
Urea (12)
C0523961 (UMLS CUI-1)
(Comment:en)
CL Item
Creatinine (13)
C0201975 (UMLS CUI-1)
(Comment:en)
CL Item
Calcium (14)
C0201925 (UMLS CUI-1)
(Comment:en)
CL Item
Bicarbonate (15)
C0202059 (UMLS CUI-1)
(Comment:en)
CL Item
Tryglyceride (16)
C0202236 (UMLS CUI-1)
(Comment:en)
CL Item
Cholesterol (17)
C0201950 (UMLS CUI-1)
(Comment:en)
CL Item
LDL (18)
C0428474 (UMLS CUI-1)
(Comment:en)
CL Item
HDL (19)
C0428472 (UMLS CUI-1)
(Comment:en)
CL Item
Uric Acid  (20)
C0202239 (UMLS CUI-1)
(Comment:en)
CL Item
Alkaline Phosphatase  (21)
C0201850 (UMLS CUI-1)
(Comment:en)
Item
Clinical Chemistry, type of result
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Clinical Chemistry, type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Clinical Chemistry Numeric Result
Item
Clinical Chemistry Numeric Result (if Numeric Result)
float
C0008000 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Clinical Chemistry Character Result
Item
Clinical Chemistry Character Result (if Character Result)
text
C0008000 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item Group
Questionnaires
C0034394 (UMLS CUI-1)
Simpson Angus Scale Score
Item
Simpson Angus Scale Score
integer
C0041755 (UMLS CUI [1,1])
C0015371 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
The Barnes Akathisia Scale Score
Item
The Barnes Akathisia Scale Score
integer
C3541345 (UMLS CUI [1])
Abnormal Involuntary Movement Scale Score
Item
Abnormal Involuntary Movement Scale Score
integer
C0450978 (UMLS CUI [1])
Profile of Mood States
Item
Profile of Mood States
text
C0451394 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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