ID

21096

Beschreibung

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

Link

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

Stichworte

Versionen (2)
  1. 08.03.17 08.03.17 -
  2. 10.04.17 10.04.17 -
Hochgeladen am

10. April 2017

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Subject information
Beschreibung

Subject information

Alias
UMLS CUI-1
C2707520
Subject identifier
Beschreibung

Subject identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit date
Beschreibung

Visit date

Alias
UMLS CUI-1
C1320303
Visit date
Beschreibung

Visit date

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1]
C1320303
Day Month Year
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
Date
Beschreibung

Date

Datentyp

date

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

Planned Relative Time

Datentyp

text

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

Planned Absolute time

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1552097
min
Actual time
Beschreibung

Actual time

Datentyp

time

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

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0871470
mmHg
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0428883
mmHg
Subject position
Beschreibung

Subject position

Datentyp

text

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

Heart Rate

Datentyp

integer

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

12-Lead-ECG

Alias
UMLS CUI-1
C0430456
Start date of ECG
Beschreibung

Start date of ECG

Datentyp

date

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

Planned Relative Time

Datentyp

text

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

Start Time of ECG

Datentyp

time

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

Ventricular Rate

Datentyp

integer

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

PR Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Invertal
Beschreibung

QTc Invertal

Datentyp

integer

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

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

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
Pharmacokinetics - Blood
Beschreibung

Pharmacokinetics - Blood

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

Time Relative to Dosing

Datentyp

text

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

Date Sample Taken

Datentyp

date

Maßeinheiten
  • 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
Beschreibung

Actual time

Datentyp

time

Maßeinheiten
  • 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
Beschreibung

Sample taken

Datentyp

text

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

Sample Number

Datentyp

text

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

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned timepoint
Beschreibung

Planned timepoint

Datentyp

text

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

Date of dose

Datentyp

date

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

Time of dose

Datentyp

time

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

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?
Beschreibung

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

Datentyp

text

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

If No, record reason(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0087111
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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