ID

24989

Descripción

Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

Palabras clave

Versiones (2)
  1. 23/8/17 23/8/17 -
  2. 4/9/17 4/9/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

23 de agosto de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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study drug compliance determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

Inglés

study drug compliance determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Descripción

patient's initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Descripción

patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
Number of Visit
Descripción

Number of Visit

Alias
UMLS CUI-1
C1549755
Number of Visit
Descripción

number of visit

Tipo de datos

integer

Alias
UMLS CUI [1]
C1549755
Return of unused study drugs
Descripción

Return of unused study drugs

Alias
UMLS CUI-1
C2699071
Has the patient returned the bottles and any unused study drug?
Descripción

study drug return

Tipo de datos

integer

Alias
UMLS CUI [1]
C2699071
Regimen: prescribed number of tablets per day
Descripción

Regimen: prescribed number of tablets per day

Alias
UMLS CUI-1
C3166216
UMLS CUI-2
C0039225
UMLS CUI-3
C0237753
Tablets Bottle 1
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 2
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 3
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 4
Descripción

only for patients in Cohort E, all others mark "NA"

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Total number of tablets dispensed at last visit
Descripción

Total number of tablets dispensed at last visit

Alias
UMLS CUI-1
C0805077
UMLS CUI-2
C0304229
Tablets Bottle 1
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 2
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 3
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 4
Descripción

only for patients in Cohort E, all others mark "NA"

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Total number of tablets returned at this visit
Descripción

Total number of tablets returned at this visit

Alias
UMLS CUI-1
C0993159
UMLS CUI-2
C2699071
Tablets Bottle 1
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 2
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 3
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 4
Descripción

only for patients in Cohort E, all others mark "NA"

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Number of tablets taken by the patient (according to the diary card)
Descripción

Number of tablets taken by the patient (according to the diary card)

Alias
UMLS CUI-1
C1290952
Tablets Bottle 1
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 2
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 3
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Tablets Bottle 4
Descripción

only for patients in Cohort E, all others mark "NA"

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
TOTAL Number of tablets taken - all bottles
Descripción

TOTAL Number of tablets taken - all bottles

Alias
UMLS CUI-1
C0039225
UMLS CUI-2
C0237753
UMLS CUI-3
C1883727
Tablets
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
TOTAL Number of tablets patient should have taken ( assuming 100% compliance)
Descripción

TOTAL Number of tablets patient should have taken ( assuming 100% compliance)

Alias
UMLS CUI-1
C0039225
UMLS CUI-2
C0237753
UMLS CUI-3
C1883727
Tablets
Descripción

number of tablets

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Patient's Compliance
Descripción

Patient's Compliance

Alias
UMLS CUI-1
C1321605
Percent compliance (Total# of tablets taken/ Total# of tablets should have taken)
Descripción

If patient is <75% compliant, notify the PAR EXEL Medical Monitor or designee)

Tipo de datos

integer

Unidades de medida
  • %
Alias
UMLS CUI [1]
C1321605
%
Tablet Count
Descripción

Tablet Count

Alias
UMLS CUI-1
C0039225
UMLS CUI-2
C0237753
Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?
Descripción

If "No", explain below.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0205197
Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?
Descripción

If No, please explain

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0205197
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Similar models

study drug compliance determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
Item Group
Number of Visit
C1549755 (UMLS CUI-1)
Item
Number of Visit
integer
C1549755 (UMLS CUI [1])
number of visit
Code List
Number of Visit
CL Item
Study Period Visit 3 (Day 4) (1)
CL Item
Study Period VIsit 4 (Day 8) (2)
Item Group
Return of unused study drugs
C2699071 (UMLS CUI-1)
Item
Has the patient returned the bottles and any unused study drug?
integer
C2699071 (UMLS CUI [1])
study drug return
Code List
Has the patient returned the bottles and any unused study drug?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Regimen: prescribed number of tablets per day
C3166216 (UMLS CUI-1)
C0039225 (UMLS CUI-2)
C0237753 (UMLS CUI-3)
number of tablets
Item
Tablets Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 2
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 3
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 4
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Total number of tablets dispensed at last visit
C0805077 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
number of tablets
Item
Tablets Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 2
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 3
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 4
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Total number of tablets returned at this visit
C0993159 (UMLS CUI-1)
C2699071 (UMLS CUI-2)
number of tablets
Item
Tablets Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 2
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 3
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 4
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Number of tablets taken by the patient (according to the diary card)
C1290952 (UMLS CUI-1)
number of tablets
Item
Tablets Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 2
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 3
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 4
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
TOTAL Number of tablets taken - all bottles
C0039225 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
C1883727 (UMLS CUI-3)
number of tablets
Item
Tablets
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
TOTAL Number of tablets patient should have taken ( assuming 100% compliance)
C0039225 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
C1883727 (UMLS CUI-3)
number of tablets
Item
Tablets
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Patient's Compliance
C1321605 (UMLS CUI-1)
compliance
Item
Percent compliance (Total# of tablets taken/ Total# of tablets should have taken)
integer
C1321605 (UMLS CUI [1])
Item Group
Tablet Count
C0039225 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Item
Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
number of tablets complete
Code List
Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?
CL Item
Yes (1)
CL Item
No (2)
Item
Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?
text
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
number of tablets complete
Code List
Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?
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