ID

25995

Description

PART A - Period 1 - PK Sampling Day - 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

Mots-clés

Versions (2)
  1. 03/10/2017 03/10/2017 -
  2. 03/10/2017 03/10/2017 -
Détendeur de droits

glaxoSmithKline

Téléchargé le

3 octobre 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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PART A - Period 1 - PK Sampling Day - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

Anglais

PART A - Period 1 - PK Sampling Day - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulaires  
Orthostatic blood pressure / Pulse - Predose
Description

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
Description

Date of visit

Type de données

date

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

Time vital signs

Type de données

time

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

Heart rate Semi-Supine

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
bpm
Heart Rate standing
Description

Heart Rate standing

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C3812758
bpm
Systolic blood pressure semi-supine
Description

Systolic blood pressure semi-supine

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure semi-supine
Description

Diastolic blood pressure semi-supine

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Systolic blood pressure standing
Description

Systolic blood pressure standing

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure standing
Description

Diastolic blood pressure standing

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C1303019
UMLS CUI [1,2]
C3812758
mmHg
Concomitant medication
Description

Concomitant medication

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

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

Type de données

integer

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

tobacco use unchanged

Type de données

integer

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

dietary restrictions

Type de données

integer

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

alcohol consumption restricted

Type de données

integer

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

Adverse event

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

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

Type de données

integer

Alias
UMLS CUI [1]
C0877248
Patient diary
Description

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.
Description

Patient diary

Type de données

text

Alias
UMLS CUI [1]
C3890583
Standard Breakfast
Description

Standard Breakfast

Alias
UMLS CUI-1
C2698559
Breakfast started
Description

Breakfast started

Type de données

time

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

Breakfast ended

Type de données

time

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

Breakfast completed

Type de données

boolean

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

Breakfast not completed comment

Type de données

text

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

Pharmacokinetics

Alias
UMLS CUI-1
C0031327
PK specimen drawn
Description

prior to dosing

Type de données

time

Unités de mesure
  • hh:mm
Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0807979
hh:mm
Study Drug Dosing
Description

Study Drug Dosing

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

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.

Type de données

float

Unités de mesure
  • mg/day
Alias
UMLS CUI [1]
C0678766
mg/day
Dosage
Description

Dosage

Type de données

integer

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

Time of Dosing

Type de données

time

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

Study medication dispensed

Type de données

integer

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

Witness 1

Type de données

text

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

Witness date 1

Type de données

date

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

Witness 2

Type de données

text

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

Witness date 2

Type de données

date

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

Study Drug Dosing - Lunch

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

Lunch start

Type de données

time

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

Lunch end

Type de données

time

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

8 hours after first dose - date

Type de données

date

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

8 hours after first dose - time

Type de données

time

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

Witness 1

Type de données

text

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

Witness date 1

Type de données

date

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

Witness 2

Type de données

text

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

Witness date 2

Type de données

date

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

Study Drug Dosing - Dinner

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

Dinner start

Type de données

time

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

Dinner end

Type de données

time

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

16 hours after first dose - date

Type de données

date

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

16 hours after first dose - time

Type de données

time

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

Witness 1

Type de données

text

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

Witness date 1

Type de données

date

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

Witness 2

Type de données

text

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

Witness date 2

Type de données

date

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

Pharmacokinetic sampling post dosing (CR)

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

Sample ID and specified time

Type de données

integer

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

Actual time sample

Type de données

time

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

Date sample

Type de données

date

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

Pharmacokinetic sampling post dosing (IR)

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

Sample ID and specified time

Type de données

integer

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

Actual time sample

Type de données

time

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

Date sample

Type de données

date

Alias
UMLS CUI [1]
C1302413
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Similar models

PART A - Period 1 - PK Sampling Day - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
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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
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CL Item
16.25h (19)
CL Item
16.5h (20)
CL Item
17h (21)
CL Item
17.5h (22)
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19h (24)
CL Item
20h (25)
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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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