ID

21094

Description

Documentation Part: Treatment Phase Day 22 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

Keywords

Versions (4)
  1. 3/4/17 3/4/17 -
  2. 3/4/17 3/4/17 -
  3. 3/8/17 3/8/17 -
  4. 4/10/17 4/10/17 -
Uploaded on

April 10, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Treatment Phase Day 22 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

English

Treatment Phase Day 22 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms  
Subject information
Description

Subject information

Alias
UMLS CUI-1
C2707520
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit date
Description

Visit date

Alias
UMLS CUI-1
C1320303
Visit date
Description

Visit date

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1]
C1320303
Day Month Year
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Day Month Year
Planned Relative Time
Description

Planned Relative Time

Data type

text

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

Planned Absolute time

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1552097
min
Actual time
Description

Actual time

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Hr : Min
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0428883
mmHg
Subject position
Description

Subject position

Data type

text

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

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
12-Lead-ECG
Description

12-Lead-ECG

Alias
UMLS CUI-1
C0430456
Start date of ECG
Description

Start date of ECG

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Day Month Year
Planned Relative Time
Description

Planned Relative Time

Data type

text

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

Start Time of ECG

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0013798
Hr : Min
Ventricular Rate
Description

Ventricular Rate

Data type

integer

Measurement units
  • Beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
Beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

QRS Duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Invertal
Description

QTc Invertal

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0860814
msec
Result of the ECG
Description

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

Data type

integer

Alias
UMLS CUI [1]
C0438154
Invesatigational product
Description

Invesatigational product

Alias
UMLS CUI-1
C3898691
Planned timepoint
Description

Planned timepoint

Data type

text

Alias
UMLS CUI [1]
C2348792
Date of dose
Description

Date of dose

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
Day Month Year
Time of dose
Description

Time of dose

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Hr : Min
Treatment confirmation
Description

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?
Description

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

Data type

text

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

If No, record reason(s)

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0087111
Ambulatory blood pressure monitoring
Description

Ambulatory blood pressure monitoring

Alias
UMLS CUI-1
C0026426
UMLS CUI-2
C0439841
Start date
Description

Start date

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0026426
UMLS CUI [1,3]
C0439841
Day Month Year
Start time
Description

Start time

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0026426
UMLS CUI [1,3]
C0439841
Hr : Min
Stop time
Description

Stop time

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0026426
UMLS CUI [1,3]
C0439841
Hr : Min
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Similar models

Treatment Phase Day 22 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Unscheduled (2)
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)
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
Invesatigational product
C3898691 (UMLS CUI-1)
Planned timepoint
Item
Planned timepoint
text
C2348792 (UMLS CUI [1])
Date of dose
Item
Date of dose
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0013227 (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
Yes (Y)
CL Item
No (N)
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])
Item Group
Ambulatory blood pressure monitoring
C0026426 (UMLS CUI-1)
C0439841 (UMLS CUI-2)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
Stop time
Item
Stop time
time
C1522314 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
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