ID

21093

Description

Documentation Part: Treatment Phase Day 15 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

Lien

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

Mots-clés

Versions (3)
  1. 04/03/2017 04/03/2017 -
  2. 08/03/2017 08/03/2017 -
  3. 10/04/2017 10/04/2017 -
Téléchargé le

10 avril 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Treatment Phase Day 15 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

Anglais

Treatment Phase Day 15 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 Formulaires  
Subject information
Description

Subject information

Alias
UMLS CUI-1
C2707520
Subject identifier
Description

Subject identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit date
Description

Visit date

Alias
UMLS CUI-1
C1320303
Visit date
Description

Visit date

Type de données

date

Unités de mesure
  • Day Month Year
Alias
UMLS CUI [1]
C1320303
Day Month Year
Urine drug screen
Description

Urine drug screen

Alias
UMLS CUI-1
C0202274
Date and time of sample taken
Description

Date and time of sample taken

Type de données

datetime

Alias
UMLS CUI [1]
C0011008
UMLS CUI [2]
C0040223
Amphetamines
Description

Amphetamines

Type de données

text

Alias
UMLS CUI [1]
C0002667
Barbiturates
Description

Barbiturates

Type de données

text

Alias
UMLS CUI [1]
C0004745
Cannabis
Description

Cannabis

Type de données

text

Alias
UMLS CUI [1]
C0936079
Cocaine
Description

Cocaine

Type de données

text

Alias
UMLS CUI [1]
C0009170
Morphine and derivatives
Description

Morphine and derivatives

Type de données

text

Alias
UMLS CUI [1]
C0279996
Alcohol test
Description

Alcohol test

Alias
UMLS CUI-1
C0868676
Date sample taken
Description

Date sample taken

Type de données

date

Unités de mesure
  • Day Month Year
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0868676
Day Month Year
Results
Description

Results

Type de données

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0868676
Pregnancy test (Complete for Female Subjects of Child-bearing Potential Only)
Description

Pregnancy test (Complete for Female Subjects of Child-bearing Potential Only)

Alias
UMLS CUI-1
C0032976
Date sample taken
Description

Date sample taken

Type de données

date

Unités de mesure
  • Day Month Year
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032976
Day Month Year
Results
Description

Results

Type de données

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0032976
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Type de données

date

Unités de mesure
  • Day Month Year
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Day Month Year
Planned Relative Time
Description

Planned Relative Time

Type de données

text

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

Planned Absolute time

Type de données

integer

Unités de mesure
  • min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1552097
min
Actual time
Description

Actual time

Type de données

time

Unités de mesure
  • Hr : Min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Hr : Min
Systolic Blood Pressure
Description

Systolic Blood Pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0428883
mmHg
Subject position
Description

Subject position

Type de données

text

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

Heart Rate

Type de données

integer

Unités de mesure
  • 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

Type de données

date

Unités de mesure
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Day Month Year
Planned Relative Time
Description

Planned Relative Time

Type de données

text

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

Start Time of ECG

Type de données

time

Unités de mesure
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0013798
Hr : Min
Ventricular Rate
Description

Ventricular Rate

Type de données

integer

Unités de mesure
  • Beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
Beats/min
PR Interval
Description

PR Interval

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

QRS Duration

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Invertal
Description

QTc Invertal

Type de données

integer

Unités de mesure
  • 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)

Type de données

integer

Alias
UMLS CUI [1]
C0438154
Invesatigational product
Description

Invesatigational product

Alias
UMLS CUI-1
C3898691
Planned timepoint
Description

Planned timepoint

Type de données

text

Alias
UMLS CUI [1,1]
C3898691
UMLS CUI [1,2]
C2348792
Date of dose
Description

Date of dose

Type de données

date

Unités de mesure
  • Day Month Year
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
Day Month Year
Time of dose
Description

Time of dose

Type de données

time

Unités de mesure
  • 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?

Type de données

text

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

If No, record reason(s)

Type de données

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

Type de données

date

Unités de mesure
  • 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

Type de données

time

Unités de mesure
  • 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

Type de données

time

Unités de mesure
  • 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 15 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Urine drug screen
C0202274 (UMLS CUI-1)
Date and time of sample taken
Item
Date and time of sample taken
datetime
C0011008 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
Item
Amphetamines
text
C0002667 (UMLS CUI [1])
Amphetamines
Code List
Amphetamines
CL Item
positive (1)
CL Item
negative (2)
Item
Barbiturates
text
C0004745 (UMLS CUI [1])
Barbiturates
Code List
Barbiturates
CL Item
positive (1)
CL Item
negative (2)
Item
Cannabis
text
C0936079 (UMLS CUI [1])
Cannabis
Code List
Cannabis
CL Item
positive (1)
CL Item
negative (2)
Item
Cocaine
text
C0009170 (UMLS CUI [1])
Cocaine
Code List
Cocaine
CL Item
positive (1)
CL Item
negative (2)
Item
Morphine and derivatives
text
C0279996 (UMLS CUI [1])
Morphine and derivatives
Code List
Morphine and derivatives
CL Item
positive (1)
CL Item
negative (2)
Item Group
Alcohol test
C0868676 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C0011008 (UMLS CUI [1,1])
C0868676 (UMLS CUI [1,2])
Item
Results
text
C0587081 (UMLS CUI [1,1])
C0868676 (UMLS CUI [1,2])
Results
Code List
Results
CL Item
positive (if positive, exclude subject from study) (1)
CL Item
negative (2)
Item Group
Pregnancy test (Complete for Female Subjects of Child-bearing Potential Only)
C0032976 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
Results
text
C0587081 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Results
Code List
Results
CL Item
positive (If positive, exclude subject from study) (1)
CL Item
negative (2)
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)
Item
Planned timepoint
text
C3898691 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Planned timepoint
Code List
Planned timepoint
CL Item
Day 12 (7)
CL Item
Day 13 (8)
CL Item
Day 14 (9)
CL Item
Extra Dose 1 (if required) (10)
CL Item
Extra Dose 2 (if required) (11)
CL Item
Day 15 (12)
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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