Informations:
Erreur:
ID
25754
Description
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 Week 12 form.
Mots-clés
Versions (1)
- 17/09/2017 17/09/2017 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
17 septembre 2017
DOI
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Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 12 101468/169 NCT00381472
GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 12 101468/169 NCT00381472
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GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 12 101468/169 NCT00381472
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
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
SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING
C0458244 (UMLS CUI-1)
Date of food diary
Item
Date of food diary
date
C0458244 (UMLS CUI [1,1])
C0458244 (UMLS CUI [1,2])
C0458244 (UMLS CUI [1,2])
Time study medication taken
Item
Time study medication taken
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Time of finishing breakfast
Item
Time of finishing breakfast:
time
C0040223 (UMLS CUI [1,1])
C2698559 (UMLS CUI [1,2])
C2698559 (UMLS CUI [1,2])
Time of finishing lunch
Item
Time of finishing lunch:
time
C0040223 (UMLS CUI [1,1])
C2697949 (UMLS CUI [1,2])
C2697949 (UMLS CUI [1,2])
Time of finishing dinner
Item
Time of finishing dinner:
time
C0040223 (UMLS CUI [1,1])
C4048877 (UMLS CUI [1,2])
C4048877 (UMLS CUI [1,2])
Item Group
SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING
C0458244 (UMLS CUI-1)
Date of food diary
Item
Date of food diary
date
C0458244 (UMLS CUI [1,1])
C0458244 (UMLS CUI [1,2])
C0458244 (UMLS CUI [1,2])
Time study medication taken
Item
Time study medication taken
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Time of finishing breakfast
Item
Time of finishing breakfast:
time
C0040223 (UMLS CUI [1,1])
C2698559 (UMLS CUI [1,2])
C2698559 (UMLS CUI [1,2])
Time of finishing lunch
Item
Time of finishing lunch:
time
C0040223 (UMLS CUI [1,1])
C2697949 (UMLS CUI [1,2])
C2697949 (UMLS CUI [1,2])
Time of finishing dinner
Item
Time of finishing dinner:
time
C0040223 (UMLS CUI [1,1])
C4048877 (UMLS CUI [1,2])
C4048877 (UMLS CUI [1,2])
Item Group
PHARMACOKINETICS - BLOOD
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0005767 (UMLS CUI-2)
pre-dose blood sample
Item
A pre-dose blood sample should be taken as soon as possible after the patient arrives at the clinic. The morning dose of study medication should be taken as soon as is practical after this blood sample (please record exact time in the CRF on the previous page.
boolean
C0178913 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
further blood samples
Item
Two further blood samples are required at this visit, one between 0.5 and 2 h after the dose taken in the clinic and one between 3 and 4 h after the dose taken in the clinic.
boolean
C0178913 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
Pre-dose Date Sample Taken
Item
Pre-dose Date Sample Taken
date
C0439565 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Pre-dose Actual Time
Item
Pre-dose Actual Time
time
C0439565 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Pre-Dose Attach Sample Identifier Label Here
Item
Pre-Dose Attach Sample Identifier Label Here
text
C0439565 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
0.5 - 2hr Post-dose Date Sample Taken
Item
0.5 - 2hr Post-dose Date Sample Taken
date
C0439568 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
0.5 - 2hr Post-dose Actual Time
Item
0.5 - 2hr Post-dose Actual Time
time
C0439568 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
0.5 - 2hr Post-dose Attach Sample Identifier Label Here
Item
0.5 - 2hr Post-dose Attach Sample Identifier Label Here
text
C0439565 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
3 - 4hr Post-dose Date Sample Taken
Item
3 - 4hr Post-dose Date Sample Taken
date
C0439568 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
3 - 4hr Post-dose Actual Time
Item
3 - 4hr Post-dose Actual Time
time
C0439568 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
3 - 4hr Post-dose Attach Sample Identifier Label Here
Item
3 - 4hr Post-dose Attach Sample Identifier Label Here
text
C0439565 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
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 (PDQ-39)
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 (PDQ-39)
Item
PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE (PDQ-39)
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])
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])
Diary Card
Item
Issue the subject with Week 16 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])
appointments
Item
Book appointments for the next three visits at Weeks 16, 20 and 24. One visit should be a morning visit and two visits should be in the afternoon. For the afternoon visits the subject may need to attend the clinic for about 5 hours.
boolean
C0805733 (UMLS CUI [1,1])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
dose of study medication
Item
If the Week 16 clinic is a morning visit, remind the subject not to take their morning dose of study medication at home on the day of the next clinic.
boolean
C0805733 (UMLS CUI [1,1])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
morning dose
Item
If the Week 16 clinic is an afternoon visit, remind the subject to take their morning dose as usual.
boolean
C0805733 (UMLS CUI [1,1])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
medication
Item
Remind the subject. To record the exact time that they took their medication on the day prior to the visit and, for afternoon appointments, on the visit day.
boolean
C0805733 (UMLS CUI [1,1])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
meals
Item
Remind the subject. To record the time that they finished their meals on the day prior to the visit.
boolean
C0805733 (UMLS CUI [1,1])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1998602 (UMLS CUI [1,4])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1998602 (UMLS CUI [1,4])