ID

21096

Beskrivning

Documentation Part: Treatment Phase Day 26-28 (PK Assessment Day) An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Länk

https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1

Nyckelord

Versioner (2)
  1. 2017-03-08 2017-03-08 -
  2. 2017-04-10 2017-04-10 -
Uppladdad den

10 april 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Treatment Phase Day 26-28 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

Engelsk

Treatment Phase Day 26-28 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 Formulär  
Subject information
Beskrivning

Subject information

Alias
UMLS CUI-1
C2707520
Subject identifier
Beskrivning

Subject identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit date
Beskrivning

Visit date

Alias
UMLS CUI-1
C1320303
Visit date
Beskrivning

Visit date

Datatyp

date

Måttenheter
  • Day Month Year
Alias
UMLS CUI [1]
C1320303
Day Month Year
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Date
Beskrivning

Date

Datatyp

date

Måttenheter
  • Day Month Year
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Day Month Year
Planned Relative Time
Beskrivning

Planned Relative Time

Datatyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Planned Absolute time
Beskrivning

Planned Absolute time

Datatyp

integer

Måttenheter
  • min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1552097
min
Actual time
Beskrivning

Actual time

Datatyp

time

Måttenheter
  • Hr : Min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Hr : Min
Systolic Blood Pressure
Beskrivning

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0871470
mmHg
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0428883
mmHg
Subject position
Beskrivning

Subject position

Datatyp

text

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

Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
12-Lead-ECG
Beskrivning

12-Lead-ECG

Alias
UMLS CUI-1
C0430456
Start date of ECG
Beskrivning

Start date of ECG

Datatyp

date

Måttenheter
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Day Month Year
Planned Relative Time
Beskrivning

Planned Relative Time

Datatyp

text

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

Start Time of ECG

Datatyp

time

Måttenheter
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0013798
Hr : Min
Ventricular Rate
Beskrivning

Ventricular Rate

Datatyp

integer

Måttenheter
  • Beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
Beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

integer

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

QRS Duration

Datatyp

integer

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

Uncorrected QT Interval

Datatyp

integer

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

QTc Invertal

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0860814
msec
Result of the ECG
Beskrivning

Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
Pharmacokinetics - Blood
Beskrivning

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Time Relative to Dosing

Datatyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
Date Sample Taken
Beskrivning

Date Sample Taken

Datatyp

date

Måttenheter
  • Day Month YearMonth Year
Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0200345
Day Month YearMonth Year
Actual time
Beskrivning

Actual time

Datatyp

time

Måttenheter
  • Hr : Min
Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0200345
Hr : Min
Sample taken
Beskrivning

Sample taken

Datatyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1277698
Sample Number
Beskrivning

Sample Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned timepoint
Beskrivning

Planned timepoint

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348792
Date of dose
Beskrivning

Date of dose

Datatyp

date

Måttenheter
  • Day Month Year
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Day Month Year
Time of dose
Beskrivning

Time of dose

Datatyp

time

Måttenheter
  • Hr : Min
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Hr : Min
Treatment Confirmation
Beskrivning

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beskrivning

Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?

Datatyp

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If No, record reason(s)
Beskrivning

If No, record reason(s)

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0087111
Tillbaka till toppen

Similar models

Treatment Phase Day 26-28 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Subject information
C2707520 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item Group
Visit date
C1320303 (UMLS CUI-1)
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
4 hrs post-dose (2)
CL Item
6 hrs post-dose (3)
CL Item
12 hrs post-dose (4)
CL Item
24 hrs post-dose (5)
CL Item
Unscheduled (6)
Planned Absolute time
Item
Planned Absolute time
integer
C0518766 (UMLS CUI [1,1])
C1552097 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0518766 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0518766 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Item
Subject position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Standing (3)
Heart Rate
Item
Heart Rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
12-Lead-ECG
C0430456 (UMLS CUI-1)
Start date of ECG
Item
Start date of ECG
date
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose 1 (1)
CL Item
Unscheduled (2)
Start Time of ECG
Item
Start Time of ECG
time
C1301880 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
QTc Invertal
Item
QTc Invertal
integer
C0430456 (UMLS CUI [1,1])
C0860814 (UMLS CUI [1,2])
Result of the ECG
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
1 hr post-dose (2)
CL Item
2 hrs post-dose (3)
CL Item
4 hrs post-dose (4)
CL Item
6 hrs post-dose (5)
CL Item
8 hrs post-dose (6)
CL Item
10 hrs post-dose (7)
CL Item
12 hrs post-dose (8)
CL Item
14 hrs post-dose (9)
CL Item
16 hrs post-dose (10)
CL Item
20 hrs post-dose (11)
CL Item
24 hrs post-dose (12)
Date Sample Taken
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
Actual time
Item
Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
Item
Sample taken
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1277698 (UMLS CUI [1,3])
Sample taken
Code List
Sample taken
CL Item
Yes (1)
CL Item
No (2)
Item
Sample Number
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Sample Number
Code List
Sample Number
CL Item
101 (1)
CL Item
102 (2)
CL Item
103 (3)
CL Item
104 (4)
CL Item
105 (5)
CL Item
106 (6)
CL Item
107 (7)
CL Item
108 (8)
CL Item
109 (9)
CL Item
110 (10)
CL Item
111 (11)
CL Item
112 (12)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Planned timepoint
text
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Planned timepoint
Code List
Planned timepoint
CL Item
Day 26 (1)
CL Item
Day 27 (2)
CL Item
Day 28 (3)
CL Item
Extra Dose 1 (if required) (4)
CL Item
Extra Dose 2 (if required) (5)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
No (N)
CL Item
Yes (Y)
If No, record reason(s)
Item
If No, record reason(s)
text
C0392360 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Tillbaka till toppen 

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