ID

25998

Beschreibung

PART A - Period 2 - Day 5 - 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

Stichworte

Versionen (1)
  1. 03.10.17 03.10.17 -
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glaxoSmithKline

Hochgeladen am

3. Oktober 2017

DOI

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PART A - Period 2 - Day 5 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

Englisch

PART A - Period 2 - Day 5 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulare  
Orthostatic blood pressure / Pulse - Predose
Beschreibung

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
Beschreibung

For the pre-dose measurements in Part A, Day 1 of Periods 1 and 2, and Part B, Day 1 of Periods 1 and 2, 3 sets of semi-supine and erect blood pressure and pulse measurements will be taken, commencing approximately 40 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi- supine position. Three stable measurements should be recorded In this instance stable is defined as the three semi-supine diastolic measurements being within 15 mmHg of the lowest measurement. This rule also applies for the semi-supine systolic and erect systolic and diastolic measurements. A maximum of six attempts can be made to obtain measurements pre-dose. If three consecutive stable measurements of blood pressure cannot be obtained then the Investigator should contact the Medical Monitor to discuss whether the patient can be included/continue in the study.

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C3812758
Heart Rate semi-supine
Beschreibung

Heart rate Semi-Supine

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
bpm
Heart Rate standing
Beschreibung

Heart Rate standing

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C3812758
bpm
Systolic blood pressure semi-supine
Beschreibung

Systolic blood pressure semi-supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure semi-supine
Beschreibung

Diastolic blood pressure semi-supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Systolic blood pressure standing
Beschreibung

Systolic blood pressure standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure standing
Beschreibung

Diastolic blood pressure standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C1303019
UMLS CUI [1,2]
C3812758
mmHg
Concomitant medication
Beschreibung

Concomitant medication

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

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

Datentyp

integer

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

tobacco use unchanged

Datentyp

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0442739
Has the subject complied with suggested dietary restrictions?
Beschreibung

dietary restrictions

Datentyp

integer

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

alcohol consumption restricted

Datentyp

text

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

Adverse event

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

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

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
Patient diary
Beschreibung

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.
Beschreibung

Patient diary

Datentyp

text

Alias
UMLS CUI [1]
C3890583
Standard Breakfast
Beschreibung

Standard Breakfast

Alias
UMLS CUI-1
C2698559
Breakfast started
Beschreibung

Breakfast started

Datentyp

time

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

Breakfast ended

Datentyp

time

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

Breakfast completed

Datentyp

boolean

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

Breakfast not completed comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0814440
UMLS CUI [1,3]
C0205197
Study Drug Dosing
Beschreibung

Study Drug Dosing

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0678766
Ropinirole 8 mg administered at
Beschreibung

The subject will not be allowed to lie down or sleep for 4 hours after the morning dose.

Datentyp

time

Maßeinheiten
  • 24hr:min
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
24hr:min
Witness 1
Beschreibung

Witness 1

Datentyp

text

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

Witness date 1

Datentyp

date

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

Witness 2

Datentyp

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness Date 2
Beschreibung

Witness Date 2

Datentyp

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Orthostatic blood pressure / pulse measurement - post dose
Beschreibung

Orthostatic blood pressure / pulse measurement - post dose

Alias
UMLS CUI-1
C1095971
UMLS CUI-2
C0232117
UMLS CUI-3
C0439568
Time point
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Post dose
Beschreibung

Post dose

Datentyp

integer

Alias
UMLS CUI [1]
C0439568
Post dose
Beschreibung

Post dose

Datentyp

integer

Alias
UMLS CUI [1]
C0439568
Time of post dose
Beschreibung

Time post dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0439568
UMLS CUI [1,2]
C0040223
Heart Rate semi-supine
Beschreibung

Heart rate Semi-Supine

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
bpm
Heart Rate standing
Beschreibung

Heart Rate standing

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C0439568
bpm
Systolic blood pressure semi-supine
Beschreibung

Systolic blood pressure semi-supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
mmHg
Diastolic blood pressure semi-supine
Beschreibung

Diastolic blood pressure semi-supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
mmHg
Systolic blood pressure standing
Beschreibung

Systolic blood pressure standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C0439568
mmHg
Diastolic blood pressure standing
Beschreibung

Diastolic blood pressure standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C0439568
mmHg
Adverse Event - 4 hours post dosing
Beschreibung

Adverse Event - 4 hours post dosing

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0439574
Has the subject experienced any Adverse Events since the time of dosing?
Beschreibung

If Yes , please document on the Adverse Event Report Forms

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
Completion of Part A
Beschreibung

Completion of Part A

Alias
UMLS CUI-1
C0805732
The subject will:
Beschreibung

check one

Datentyp

integer

Alias
UMLS CUI [1]
C2348568
Discharge
Beschreibung

Discharge

Alias
UMLS CUI-1
C0030685
Time of discharge from study site
Beschreibung

Advise the subject to refrain from consuming xanthine containing beverages and foods (Coffee, tea, cola beverages, cocoa chocolate), grapefruit containing products, quinine - containing products and food containing CYP1A2-inducing constituents (Brussel sprouts, broccoli, cabbage, etc ), from 24 h before the PK evaluation day, Periods 1 and 2 in Part B, until completion of assessments 24 h afterwards

Datentyp

time

Alias
UMLS CUI [1]
C3864299
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Ähnliche Modelle

PART A - Period 2 - Day 5 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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 complied with suggested dietary restrictions?
integer
C0425422 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
dietary restrictions
Code List
Has the subject complied with suggested dietary restrictions?
CL Item
Yes (1)
CL Item
No (2)
Item
Has the subject continued to refrain from alcohol consumption as instructed?
text
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
Study Drug Dosing
C0013175 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
Time of Dosing
Item
Ropinirole 8 mg administered at
time
C0178602 (UMLS CUI [1,1])
C0040223 (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
Orthostatic blood pressure / pulse measurement - post dose
C1095971 (UMLS CUI-1)
C0232117 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date of visit
Item
Time point
date
C1320303 (UMLS CUI [1])
Item
Post dose
integer
C0439568 (UMLS CUI [1])
Post dose
Code List
Post dose
CL Item
1h post dose (1)
CL Item
2h post dose (2)
CL Item
3h post dose (3)
CL Item
4h post dose (4)
Item
Post dose
integer
C0439568 (UMLS CUI [1])
Post dose
Code List
Post dose
CL Item
1h post dose (1)
CL Item
2h post dose (2)
CL Item
3h post dose (3)
CL Item
4h post dose (4)
Time post dose
Item
Time of post dose
time
C0439568 (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])
C0439568 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C0439568 (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])
C0439568 (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])
C0439568 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Item Group
Adverse Event - 4 hours post dosing
C0877248 (UMLS CUI-1)
C0439574 (UMLS CUI-2)
Item
Has the subject experienced any Adverse Events since the time of dosing?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Has the subject experienced any Adverse Events since the time of dosing?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Completion of Part A
C0805732 (UMLS CUI-1)
Item
The subject will:
integer
C2348568 (UMLS CUI [1])
Study subject participation status
Code List
The subject will:
CL Item
Enter Part B (will continue on ropinirole 8 mg OD between Parts A and B) (1)
CL Item
Discontinue from the study. (2)
Item Group
Discharge
C0030685 (UMLS CUI-1)
Discharge Time
Item
Time of discharge from study site
time
C3864299 (UMLS CUI [1])
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