ID

25997

Descripción

PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Palabras clave

Versiones (1)
  1. 3/10/17 3/10/17 -
Titular de derechos de autor

glaxoSmithKline

Subido en

3 de octubre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

Inglés

PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 formularios  
Orthostatic blood pressure / Pulse - Predose
Descripción

Orthostatic blood pressure / Pulse - Predose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1095971
UMLS CUI-3
C0232117
UMLS CUI-4
C3812758
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C3812758
Time
Descripción

Time vital signs

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Heart Rate semi-supine
Descripción

Heart rate Semi-Supine

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
bpm
Heart Rate standing
Descripción

Heart Rate standing

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C3812758
bpm
Systolic blood pressure semi-supine
Descripción

Systolic blood pressure semi-supine

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure semi-supine
Descripción

Diastolic blood pressure semi-supine

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Systolic blood pressure standing
Descripción

Systolic blood pressure standing

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure standing
Descripción

Diastolic blood pressure standing

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C1303019
UMLS CUI [1,2]
C3812758
mmHg
Concomitant medication
Descripción

Concomitant medication

Alias
UMLS CUI-1
C2347852
Has the subject had any changes in medication since the last study visit?
Descripción

If 'Yes', please document on the Concomitant Medication Report Forms.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0580105
Have the subject's smoking habits remained unchanged?
Descripción

tobacco use unchanged

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0442739
Has the subject been reminded to comply with suggested dietary restrictions?
Descripción

dietary restrictions

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0425422
UMLS CUI [1,2]
C1321605
Has the subject continued to refrain from alcohol consumption as instructed?
Descripción

alcohol consumption restricted

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0443288
Adverse event
Descripción

Adverse event

Alias
UMLS CUI-1
C0877248
Has the subject experienced any Adverse Events since the last study contact?
Descripción

If 'Yes', please document on the Adverse Event Report Forms.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0877248
Patient diary
Descripción

Patient diary

Alias
UMLS CUI-1
C3890583
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
Descripción

Patient diary

Tipo de datos

text

Alias
UMLS CUI [1]
C3890583
Standard Breakfast
Descripción

Standard Breakfast

Alias
UMLS CUI-1
C2698559
Breakfast started
Descripción

Breakfast started

Tipo de datos

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439659
Breakfast ended
Descripción

Breakfast ended

Tipo de datos

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0444930
Did the subject complete the breakfast?
Descripción

Breakfast completed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0814440
UMLS CUI [1,2]
C0205197
If no, please comment:
Descripción

Breakfast not completed comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0814440
UMLS CUI [1,3]
C0205197
Pharmacokinetics
Descripción

Pharmacokinetics

Alias
UMLS CUI-1
C0031327
PK specimen drawn
Descripción

prior to dosing

Tipo de datos

time

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0807979
hh:mm
Study Drug Dosing
Descripción

Study Drug Dosing

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0678766
Dosage given
Descripción

The subject will not be allowed to lie down or sleep for 4 hours after the morning dose. For subjects receiving IR please document time of administration of 2 further doses on PK Sampling Day.

Tipo de datos

float

Unidades de medida
  • mg/day
Alias
UMLS CUI [1]
C0678766
mg/day
Dosage
Descripción

Dosage

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C3854006
Time of dosing
Descripción

Time of Dosing

Tipo de datos

time

Unidades de medida
  • 24hr:min
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
24hr:min
Was study medication dispensed to the subject?
Descripción

Study medication dispensed

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0947323
Witness 1
Descripción

Witness 1

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness date 1
Descripción

Witness date 1

Tipo de datos

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Witness 2
Descripción

Witness 2

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness date 2
Descripción

Witness date 2

Tipo de datos

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Study Drug Dosing - Lunch
Descripción

Study Drug Dosing - Lunch

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0678766
UMLS CUI-3
C2697949
Lunch started
Descripción

Lunch start

Tipo de datos

time

Alias
UMLS CUI [1,1]
C2697949
UMLS CUI [1,2]
C0439659
Lunch ended
Descripción

Lunch end

Tipo de datos

time

Alias
UMLS CUI [1,1]
C2697949
UMLS CUI [1,2]
C0444930
8 hours after first dose - date
Descripción

8 hours after first dose - date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0439568
8 hours after first dose - time
Descripción

8 hours after first dose - time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0439568
Witness 1
Descripción

Witness 1

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness date 1
Descripción

Witness date 1

Tipo de datos

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Witness 2
Descripción

Witness 2

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness date 2
Descripción

Witness date 2

Tipo de datos

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Study Drug Dosing - Dinner
Descripción

Study Drug Dosing - Dinner

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0678766
UMLS CUI-3
C4048877
Dinner started
Descripción

Dinner start

Tipo de datos

time

Alias
UMLS CUI [1,1]
C4048877
UMLS CUI [1,2]
C0439659
Dinner ended
Descripción

Dinner end

Tipo de datos

time

Alias
UMLS CUI [1,1]
C4048877
UMLS CUI [1,2]
C0444930
16 hours after first dose - date
Descripción

16 hours after first dose - date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0439568
16 hours after first dose - time
Descripción

16 hours after first dose - time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0439568
Witness 1
Descripción

Witness 1

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness date 1
Descripción

Witness date 1

Tipo de datos

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Witness 2
Descripción

Witness 2

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness date 2
Descripción

Witness date 2

Tipo de datos

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Pharmacokinetic sampling post dosing (CR)
Descripción

Pharmacokinetic sampling post dosing (CR)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0370003
Sample ID and specified time
Descripción

Sample ID and specified time

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C1444698
Actual time
Descripción

Actual time sample

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0040223
Date
Descripción

Date sample

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Pharmacokinetic sampling post dosing (IR)
Descripción

Pharmacokinetic sampling post dosing (IR)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0370003
Sample ID and specified time
Descripción

Sample ID and specified time

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C1444698
Actual time
Descripción

Actual time sample

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0040223
Date
Descripción

Date sample

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
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Similar models

PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Orthostatic blood pressure / Pulse - Predose
C0518766 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
C3812758 (UMLS CUI-4)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Time vital signs
Item
Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C1303019 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Item
Has the subject had any changes in medication since the last study visit?
integer
C0580105 (UMLS CUI [1])
changes in medication
Code List
Has the subject had any changes in medication since the last study visit?
CL Item
Yes (1)
CL Item
No (2)
Item
Have the subject's smoking habits remained unchanged?
integer
C0543414 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
tobacco use unchanged
Code List
Have the subject's smoking habits remained unchanged?
CL Item
Yes (1)
CL Item
No (2)
Item
Has the subject been reminded to comply with suggested dietary restrictions?
integer
C0425422 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
dietary restrictions
Code List
Has the subject been reminded to comply with suggested dietary restrictions?
CL Item
Yes (1)
CL Item
No (2)
Item
Has the subject continued to refrain from alcohol consumption as instructed?
integer
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
alcohol consumption restricted
Code List
Has the subject continued to refrain from alcohol consumption as instructed?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any Adverse Events since the last study contact?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Has the subject experienced any Adverse Events since the last study contact?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Patient diary
C3890583 (UMLS CUI-1)
Patient diary
Item
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
text
C3890583 (UMLS CUI [1])
Item Group
Standard Breakfast
C2698559 (UMLS CUI-1)
Breakfast started
Item
Breakfast started
time
C2698559 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Breakfast ended
Item
Breakfast ended
time
C2698559 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
Breakfast completed
Item
Did the subject complete the breakfast?
boolean
C0814440 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Breakfast not completed comment
Item
If no, please comment:
text
C0947611 (UMLS CUI [1,1])
C0814440 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Item Group
Pharmacokinetics
C0031327 (UMLS CUI-1)
Pharmacokinetics
Item
PK specimen drawn
time
C0031327 (UMLS CUI [1,1])
C0807979 (UMLS CUI [1,2])
Item Group
Study Drug Dosing
C0013175 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
Dosage given
Item
Dosage given
float
C0678766 (UMLS CUI [1])
Item
Dosage
integer
C0178602 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Dosage
Code List
Dosage
CL Item
CR (1)
CL Item
IR (2)
Time of Dosing
Item
Time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Was study medication dispensed to the subject?
integer
C3854006 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Study medication dispensed
Code List
Was study medication dispensed to the subject?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Witness 1
Item
Witness 1
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date 1
Item
Witness date 1
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Witness 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date 2
Item
Witness date 2
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Study Drug Dosing - Lunch
C0013175 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
C2697949 (UMLS CUI-3)
Lunch start
Item
Lunch started
time
C2697949 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Lunch end
Item
Lunch ended
time
C2697949 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
8 hours after first dose - date
Item
8 hours after first dose - date
date
C0011008 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
8 hours after first dose - time
Item
8 hours after first dose - time
time
C0040223 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Witness 1
Item
Witness 1
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date 1
Item
Witness date 1
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Witness 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date 2
Item
Witness date 2
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Study Drug Dosing - Dinner
C0013175 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
C4048877 (UMLS CUI-3)
Dinner start
Item
Dinner started
time
C4048877 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Dinner end
Item
Dinner ended
time
C4048877 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
16 hours after first dose - date
Item
16 hours after first dose - date
date
C0011008 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
16 hours after first dose - time
Item
16 hours after first dose - time
time
C0040223 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Witness 1
Item
Witness 1
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date 1
Item
Witness date 1
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Witness 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date 2
Item
Witness date 2
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Pharmacokinetic sampling post dosing (CR)
C0031328 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
Item
Sample ID and specified time
integer
C1299222 (UMLS CUI [1,1])
C1444698 (UMLS CUI [1,2])
Sample ID and specified time
Code List
Sample ID and specified time
CL Item
1h (1)
CL Item
2h (2)
CL Item
4h (3)
CL Item
6h (4)
CL Item
8h (5)
CL Item
10h (6)
CL Item
12h (7)
CL Item
14h (8)
CL Item
16h (9)
CL Item
20h (10)
CL Item
24h (11)
Actual time sample
Item
Actual time
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date sample
Item
Date
date
C1302413 (UMLS CUI [1])
Item Group
Pharmacokinetic sampling post dosing (IR)
C0031328 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
Item
Sample ID and specified time
integer
C1299222 (UMLS CUI [1,1])
C1444698 (UMLS CUI [1,2])
Sample ID and specified time
Code List
Sample ID and specified time
CL Item
0.25h (1)
CL Item
0.5h (2)
CL Item
1.0h (3)
CL Item
1.5h (4)
CL Item
2h (5)
CL Item
3h (6)
CL Item
4h (7)
CL Item
6h (8)
CL Item
8h (9)
CL Item
8.25h (10)
CL Item
8.5h (11)
CL Item
9h (12)
CL Item
9.5h (13)
CL Item
10h (14)
CL Item
11h (15)
CL Item
12h (16)
CL Item
14h (17)
CL Item
16h (18)
CL Item
16.25h (19)
CL Item
16.5h (20)
CL Item
17h (21)
CL Item
17.5h (22)
CL Item
18h (23)
CL Item
19h (24)
CL Item
20h (25)
CL Item
22h (26)
CL Item
24h (27)
Actual time sample
Item
Actual time
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date sample
Item
Date
date
C1302413 (UMLS CUI [1])
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