Informatie:
Fout:
ID
25740
Beschrijving
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.
Trefwoorden
Versies (1)
- 17-09-17 17-09-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
17 september 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 0 101468/169 NCT00381472
GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 0 101468/169 NCT00381472
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GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 0 101468/169 NCT00381472
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Date of diary day 1
Item
Date of diary day 1
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Total time asleep
Item
Total time asleep
time
C0040223 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,2])
awake time off
Item
Total awake time ’Off’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
C0234422 (UMLS CUI [1,2])
awake time On
Item
Total awake time ’On’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
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])
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])
C0011008 (UMLS CUI [1,2])
Total time asleep
Item
Total time asleep
time
C0040223 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,2])
awake time Off
Item
Total awake time ’Off’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
C0234422 (UMLS CUI [1,2])
awake time On
Item
Total awake time ’On’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
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])
C0234422 (UMLS CUI [1,2])
C0013384 (UMLS CUI [1,3])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (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])
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])
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)
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])
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])
C0023570 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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])
C0023570 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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])
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)
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])
C0030567 (UMLS CUI [1,2])
Item Group
PARKINSON’S DISEASE SLEEP SCALE
C0030567 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
C0037313 (UMLS CUI-3)
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])
C0030567 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
BECK DEPRESSION INVENTORY
Item
BECK DEPRESSION INVENTORY
boolean
C0451022 (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)
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])
C0030567 (UMLS CUI [1,2])
C0034380 (UMLS CUI [1,3])
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (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])
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])
C0010340 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0013798 (UMLS CUI [1,4])
Blinded Dose Level
Item
Blinded Dose Level
integer
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
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])
C0449788 (UMLS CUI [1,2])
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
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])
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])
C0304229 (UMLS CUI [1,2])
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])
C0013230 (UMLS CUI [1,2])
Randomisation Number
Item
Record randomisation number.
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
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])
C3812666 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])