ID

25740

Beschreibung

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Screening 0 form.

Stichworte

Versionen (1)
  1. 17.09.17 17.09.17 -
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GlaxoSmithKline

Hochgeladen am

17. September 2017

DOI

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GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 0 101468/169 NCT00381472

Englisch

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 0 101468/169 NCT00381472

1 Formulare  
DIARY INFORMATION
Beschreibung

DIARY INFORMATION

Alias
UMLS CUI-1
C3890583
Date of diary day 1
Beschreibung

Date of diary day 1

Datentyp

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
Total time asleep
Beschreibung

Total time asleep

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0037313
Total awake time ’Off’
Beschreibung

awake time off

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
Total awake time ’On’
Beschreibung

awake time On

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
Total awake time "On" with troublesome dyskinesias
Beschreibung

awake time dyskinesias

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
UMLS CUI [1,3]
C0013384
Date of diary day 2
Beschreibung

Date of diary day 2

Datentyp

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
Total time asleep
Beschreibung

Total time asleep

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0037313
Total awake time ’Off’
Beschreibung

awake time Off

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
Total awake time ’On’
Beschreibung

awake time On

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
Total awake time "On" with troublesome dyskinesias
Beschreibung

awake time dyskinesias

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
UMLS CUI [1,3]
C0013384
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
SUBJECT CONTINUATION
Beschreibung

SUBJECT CONTINUATION

Alias
UMLS CUI-1
C0805733
If the subject is not continuing in the study, do not complete this visit but enter appropriate details on the Study Conclusion page. Continuing?
Beschreibung

Subject continuation

Datentyp

boolean

Alias
UMLS CUI [1]
C0805733
ADVERSE EVENTS PROMPT
Beschreibung

ADVERSE EVENTS PROMPT

Record details of any new adverse events/serious adverse events observed or reported by the subject or any changes to ongoing adverse events in the appropriate Adverse Events/Serious Adverse Events section.
Beschreibung

Adverse Events

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
CONCOMITANT MEDICATION PROMPT
Beschreibung

CONCOMITANT MEDICATION PROMPT

Alias
UMLS CUI-1
C2347852
Record any changes to the subject’s concomitant medication or any new medications taken since the last visit in the appropriate Concomitant Medication section.
Beschreibung

Concomitant Medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
L-DOPA MEDICATION CHANGES
Beschreibung

L-DOPA MEDICATION CHANGES

Alias
UMLS CUI-1
C0023570
UMLS CUI-2
C0023570
Has there been any change in dose or frequency of L-Dopa medication since the last visit?
Beschreibung

change L-Dopa medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0023570
If Yes, tick the primary reason for change:
Beschreibung

reason for change

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0023570
UMLS CUI [1,3]
C0392360
Other, specify
Beschreibung

reason for change

Datentyp

text

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0023570
UMLS CUI [1,3]
C0392360
VITAL SIGNS
Beschreibung

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Blood Pressure Systolic
Beschreibung

Semi-Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure Diastolic
Beschreibung

Semi-Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Beschreibung

Semi-Supine

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Blood Pressure Systolic
Beschreibung

Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure Diastolic
Beschreibung

Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Beschreibung

Standing

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
CLINICAL GLOBAL IMPRESSION
Beschreibung

CLINICAL GLOBAL IMPRESSION

Alias
UMLS CUI-1
C3639708
CLINICAL GLOBAL IMPRESSION
Beschreibung

CLINICAL GLOBAL IMPRESSION

Datentyp

boolean

Alias
UMLS CUI [1]
C3639708
UNIFIED PARKINSONS DISEASE RATING SCALE
Beschreibung

UNIFIED PARKINSONS DISEASE RATING SCALE

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0030567
UNIFIED PARKINSONS DISEASE RATING SCALE
Beschreibung

UNIFIED PARKINSONS DISEASE RATING SCALE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0030567
PARKINSON’S DISEASE SLEEP SCALE
Beschreibung

PARKINSON’S DISEASE SLEEP SCALE

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0030567
UMLS CUI-3
C0037313
PARKINSON’S DISEASE SLEEP SCALE
Beschreibung

PARKINSON’S DISEASE SLEEP SCALE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0030567
UMLS CUI [1,3]
C0037313
BECK DEPRESSION INVENTORY
Beschreibung

BECK DEPRESSION INVENTORY

Alias
UMLS CUI-1
C0451022
BECK DEPRESSION INVENTORY
Beschreibung

BECK DEPRESSION INVENTORY

Datentyp

boolean

Alias
UMLS CUI [1]
C0451022
EPWORTH SLEEPINESS SCALE
Beschreibung

EPWORTH SLEEPINESS SCALE

Alias
UMLS CUI-1
C3541276
EPWORTH SLEEPINESS SCALE
Beschreibung

EPWORTH SLEEPINESS SCALE

Datentyp

boolean

Alias
UMLS CUI [1]
C3541276
PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE
Beschreibung

PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0030567
UMLS CUI-3
C0034380
PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE
Beschreibung

PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0030567
UMLS CUI [1,3]
C0034380
ELIGIBILITY QUESTION
Beschreibung

ELIGIBILITY QUESTION

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschreibung

Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
INCLUSION CRITERIA
Beschreibung

INCLUSION CRITERIA

Alias
UMLS CUI-1
C1512693
A minimum of 3 hours awake “time–off” for each diary day recorded during the Placebo Run-In Period.
Beschreibung

awake time–off

Datentyp

boolean

Alias
UMLS CUI [1]
C1718390
EXCLUSION CRITERIA
Beschreibung

EXCLUSION CRITERIA

Alias
UMLS CUI-1
C0680251
Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG.
Beschreibung

abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0010340
UMLS CUI [1,3]
C0031809
UMLS CUI [1,4]
C0013798
INVESTIGATIONAL PRODUCT
Beschreibung

INVESTIGATIONAL PRODUCT

Alias
UMLS CUI-1
C0304229
Blinded Dose Level
Beschreibung

Blinded Dose Level

Datentyp

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0304229
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Investigational product Container Number
Beschreibung

Investigational product Container Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C3898691
UMLS CUI [1,2]
C0449788
COMPLIANCE
Beschreibung

COMPLIANCE

Alias
UMLS CUI-1
C1321605
Total number of Tablets Dispensed
Beschreibung

Total number of Tablets Dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Total number of Tablets Returned
Beschreibung

Total number of Tablets Returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Has the subject missed investigational product for more than 3 consecutive days?
Beschreibung

Has the subject missed investigational product for more than 3 consecutive days?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0304229
DISPENSING
Beschreibung

DISPENSING

Alias
UMLS CUI-1
C0947323
Record dispensing information in the Investigational Product and Compliance sections at the next visit.
Beschreibung

Dispense investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0013230
RANDOMISATION NUMBER
Beschreibung

RANDOMISATION NUMBER

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number.
Beschreibung

Randomisation Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
DIARY CARD
Beschreibung

DIARY CARD

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C3812666
UMLS CUI-3
C1457887
Issue the subject with Week 1 Diary Card
Beschreibung

Diary Card

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C3812666
UMLS CUI [1,3]
C1457887
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Ähnliche Modelle

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 0 101468/169 NCT00381472

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
DIARY INFORMATION
C3890583 (UMLS CUI-1)
Date of diary day 1
Item
Date of diary day 1
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Total time asleep
Item
Total time asleep
time
C0040223 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
awake time off
Item
Total awake time ’Off’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
awake time On
Item
Total awake time ’On’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
awake time dyskinesias
Item
Total awake time "On" with troublesome dyskinesias
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
C0013384 (UMLS CUI [1,3])
Date of diary day 2
Item
Date of diary day 2
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Total time asleep
Item
Total time asleep
time
C0040223 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
awake time Off
Item
Total awake time ’Off’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
awake time On
Item
Total awake time ’On’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
awake time dyskinesias
Item
Total awake time "On" with troublesome dyskinesias
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
C0013384 (UMLS CUI [1,3])
Item Group
General Information
C1508263 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
SUBJECT CONTINUATION
C0805733 (UMLS CUI-1)
Subject continuation
Item
If the subject is not continuing in the study, do not complete this visit but enter appropriate details on the Study Conclusion page. Continuing?
boolean
C0805733 (UMLS CUI [1])
Item Group
ADVERSE EVENTS PROMPT
Adverse Events
Item
Record details of any new adverse events/serious adverse events observed or reported by the subject or any changes to ongoing adverse events in the appropriate Adverse Events/Serious Adverse Events section.
boolean
C0877248 (UMLS CUI [1])
Item Group
CONCOMITANT MEDICATION PROMPT
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Record any changes to the subject’s concomitant medication or any new medications taken since the last visit in the appropriate Concomitant Medication section.
boolean
C2347852 (UMLS CUI [1])
Item Group
L-DOPA MEDICATION CHANGES
C0023570 (UMLS CUI-1)
C0023570 (UMLS CUI-2)
change L-Dopa medication
Item
Has there been any change in dose or frequency of L-Dopa medication since the last visit?
boolean
C0023570 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
Item
If Yes, tick the primary reason for change:
integer
C0023570 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for change
Code List
If Yes, tick the primary reason for change:
CL Item
Reduction required by protocol (starting at dose level 4)  (1)
CL Item
Unacceptable dopaminergic side-effect (Record in the Adverse Events section)  (2)
CL Item
Loss of efficacy  (3)
CL Item
Other, specify (4)
reason for change
Item
Other, specify
text
C0023570 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
CLINICAL GLOBAL IMPRESSION
C3639708 (UMLS CUI-1)
CLINICAL GLOBAL IMPRESSION
Item
CLINICAL GLOBAL IMPRESSION
boolean
C3639708 (UMLS CUI [1])
Item Group
UNIFIED PARKINSONS DISEASE RATING SCALE
C0030567 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
UNIFIED PARKINSONS DISEASE RATING SCALE
Item
UNIFIED PARKINSONS DISEASE RATING SCALE
boolean
C0030567 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Item Group
PARKINSON’S DISEASE SLEEP SCALE
C0030567 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
C0037313 (UMLS CUI-3)
PARKINSON’S DISEASE SLEEP SCALE
Item
PARKINSON’S DISEASE SLEEP SCALE
boolean
C0030567 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
Item Group
BECK DEPRESSION INVENTORY
C0451022 (UMLS CUI-1)
BECK DEPRESSION INVENTORY
Item
BECK DEPRESSION INVENTORY
boolean
C0451022 (UMLS CUI [1])
Item Group
EPWORTH SLEEPINESS SCALE
C3541276 (UMLS CUI-1)
EPWORTH SLEEPINESS SCALE
Item
EPWORTH SLEEPINESS SCALE
boolean
C3541276 (UMLS CUI [1])
Item Group
PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE
C0030567 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
C0034380 (UMLS CUI-3)
PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE
Item
PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE
boolean
C0030567 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0034380 (UMLS CUI [1,3])
Item Group
ELIGIBILITY QUESTION
C1516637 (UMLS CUI-1)
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
INCLUSION CRITERIA
C1512693 (UMLS CUI-1)
awake time–off
Item
A minimum of 3 hours awake “time–off” for each diary day recorded during the Placebo Run-In Period.
boolean
C1718390 (UMLS CUI [1])
Item Group
EXCLUSION CRITERIA
C0680251 (UMLS CUI-1)
abnormality
Item
Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG.
boolean
C1704258 (UMLS CUI [1,1])
C0010340 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0013798 (UMLS CUI [1,4])
Item Group
INVESTIGATIONAL PRODUCT
C0304229 (UMLS CUI-1)
Blinded Dose Level
Item
Blinded Dose Level
integer
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product Container Number
Item
Investigational product Container Number
integer
C3898691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
COMPLIANCE
C1321605 (UMLS CUI-1)
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Has the subject missed investigational product for more than 3 consecutive days?
Item
Has the subject missed investigational product for more than 3 consecutive days?
boolean
C1321605 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
DISPENSING
C0947323 (UMLS CUI-1)
Dispense investigational product
Item
Record dispensing information in the Investigational Product and Compliance sections at the next visit.
boolean
C0947323 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Item Group
RANDOMISATION NUMBER
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
Record randomisation number.
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
DIARY CARD
C3890583 (UMLS CUI-1)
C3812666 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
Diary Card
Item
Issue the subject with Week 1 Diary Card
boolean
C3890583 (UMLS CUI [1,1])
C3812666 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
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