ID

25295

Beschreibung

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

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Versionen (2)
  1. 31.08.17 31.08.17 -
  2. 04.09.17 04.09.17 -
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GlaxoSmithKline

Hochgeladen am

31. August 2017

DOI

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Patient's Daily Study Drug Diary determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

Englisch

Patient's Daily Study Drug Diary determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 Formulare  
Study Drug Diary
Beschreibung

Study Drug Diary

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0376660
Study Day
Beschreibung

Fulfill the following items for each study day separately.

Datentyp

text

Alias
UMLS CUI [1]
C2826182
DATE
Beschreibung

date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
MORNING DOSE : Time
Beschreibung

time of morning dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332170
MORNING DOSE: Number of Tablets Taken: Bottle 1
Beschreibung

number of tablets taken in morning dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1883727
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332170
MORNING DOSE: Number of Tablets Taken: Bottle 2
Beschreibung

number of tablets taken in morning dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1883727
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332170
MORNING DOSE: Number of Tablets Taken: Bottle 3
Beschreibung

number of tablets taken in morning dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1883727
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332170
MORNING DOSE: Number of Tablets Taken: Bottle 4
Beschreibung

number of tablets taken in morning dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1883727
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332170
NOON DOSE : Time
Beschreibung

time of noon dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0585020
NOON DOSE : Number of Tablets Taken : Bottle 1
Beschreibung

number of tablets taken in noon dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1883727
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0585020
EVENING DOSE : Time
Beschreibung

time of evening dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0587117
EVENING DOSE : Number of Tablets Taken : Bottle 1
Beschreibung

number of tablets taken in evening dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1883727
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0587117
CONCOMITANT MEDICATIONS
Beschreibung

CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
Name of Drug
Beschreibung

Generic name if possible

Datentyp

text

Alias
UMLS CUI [1]
C3273235
Total Dose
Beschreibung

units/dose

Datentyp

integer

Alias
UMLS CUI [1]
C2986497
Date Taken
Beschreibung

date medication taken

Datentyp

date

Alias
UMLS CUI [1]
C2826734
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Ähnliche Modelle

Patient's Daily Study Drug Diary determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Study Drug Diary
C0304229 (UMLS CUI-1)
C0376660 (UMLS CUI-2)
Item
Study Day
text
C2826182 (UMLS CUI [1])
study day
Code List
Study Day
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
date
Item
DATE
date
C0011008 (UMLS CUI [1])
time of morning dose
Item
MORNING DOSE : Time
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
number of tablets taken in morning dose
Item
MORNING DOSE: Number of Tablets Taken: Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332170 (UMLS CUI [2,2])
number of tablets taken in morning dose
Item
MORNING DOSE: Number of Tablets Taken: Bottle 2
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332170 (UMLS CUI [2,2])
number of tablets taken in morning dose
Item
MORNING DOSE: Number of Tablets Taken: Bottle 3
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332170 (UMLS CUI [2,2])
number of tablets taken in morning dose
Item
MORNING DOSE: Number of Tablets Taken: Bottle 4
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332170 (UMLS CUI [2,2])
time of noon dose
Item
NOON DOSE : Time
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0585020 (UMLS CUI [1,3])
number of tablets taken in noon dose
Item
NOON DOSE : Number of Tablets Taken : Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0585020 (UMLS CUI [2,2])
time of evening dose
Item
EVENING DOSE : Time
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
number of tablets taken in evening dose
Item
EVENING DOSE : Number of Tablets Taken : Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0587117 (UMLS CUI [2,2])
Item Group
CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
name of drug
Item
Name of Drug
text
C3273235 (UMLS CUI [1])
total dose
Item
Total Dose
integer
C2986497 (UMLS CUI [1])
date medication taken
Item
Date Taken
date
C2826734 (UMLS CUI [1])
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