ID

40759

Beschreibung

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Stichworte

Versionen (3)
  1. 24.04.20 24.04.20 -
  2. 30.04.20 30.04.20 -
  3. 08.05.20 08.05.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

8. Mai 2020

DOI

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Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

Englisch

Smoking History; RLS Pharmacotherapy History; Vital Signs; 12 Lead ECG Monitoring

1 Formulare  
Patient administration
Beschreibung

Patient administration

Alias
UMLS CUI-1
C1320722
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Smoking History (Screening)
Beschreibung

Smoking History (Screening)

Alias
UMLS CUI-1
C1519384
Is the subject a smoker?
Beschreibung

If yes, please complete smoking history details.

Datentyp

boolean

Alias
UMLS CUI [1]
C1519386
Number of years the subject has been a smoker?
Beschreibung

Number of years the subject has been a smoker?

Datentyp

integer

Maßeinheiten
  • Yrs
Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
Yrs
Average number of cigarettes smoked per day?
Beschreibung

Average number of cigarettes smoked per day?

Datentyp

integer

Alias
UMLS CUI [1]
C1608325
Please state what type of tobacco product (eg. pipe, cigar, chewing tobacco or cigarette)
Beschreibung

Please state what type of tobacco product (eg. pipe, cigar, chewing tobacco or cigarette)

Datentyp

text

Alias
UMLS CUI [1]
C3166496
UMLS CUI [2]
C0678447
UMLS CUI [3]
C0678446
UMLS CUI [4]
C0241410
UMLS CUI [5]
C0677453
RLS Pharmacotherapy History (Screening)
Beschreibung

RLS Pharmacotherapy History (Screening)

Alias
UMLS CUI-1
C0013216
UMLS CUI-2
C0035258
Has the patient taken any pharmacotherapy medication for treatment of RLS?
Beschreibung

If yes, please record details below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0035258
RLS Pharmacotherapy History (Screening)
Beschreibung

RLS Pharmacotherapy History (Screening)

Alias
UMLS CUI-1
C0013216
UMLS CUI-2
C0035258
RLS Pharmacotherapy - Drug Name
Beschreibung

Trade Name Preferred

Datentyp

text

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0035258
UMLS CUI [2]
C2360065
RLS Pharmacotherapy - Start Date
Beschreibung

be as precise as possible

Datentyp

date

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0808070
RLS Pharmacotherapy - End date
Beschreibung

RLS Pharmacotherapy - End date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0806020
RLS Pharmacotherapy - Continuing
Beschreibung

RLS Pharmacotherapy - Continuing

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0549178
RLS Pharmacotherapy - Did the patient respond to the treatment?
Beschreibung

RLS Pharmacotherapy - Did the patient respond to the treatment?

Datentyp

text

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0035258
UMLS CUI [2]
C0521982
RLS Pharmacotherapy - Did the patient tolerate the treatment?
Beschreibung

RLS Pharmacotherapy - Did the patient tolerate the treatment?

Datentyp

text

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0035258
UMLS CUI [2]
C0013220
Vital Signs (Screening)
Beschreibung

Vital Signs (Screening)

Alias
UMLS CUI-1
C0518766
Vital Signs - Date and Time
Beschreibung

Vital Signs - Date and Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Vital Signs - Semi-supine BP Systolic
Beschreibung

Vital Signs - Semi-supine BP Systolic

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522019
mm[Hg]
Vital Signs - Semi-supine BP Diastolic
Beschreibung

Vital Signs - Semi-supine BP Diastolic

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522019
mm[Hg]
Vital Signs - Semi-supine Hear Rate
Beschreibung

Vital Signs - Semi-supine Hear Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522019
beats/min
Vital Signs - Time
Beschreibung

Vital Signs - Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Vital Signs - Erect BP Systolic
Beschreibung

Vital Signs - Erect BP Systolic

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522014
mm[Hg]
Vital Signs - Erect BP Diastolic
Beschreibung

Vital Signs - Erect BP Diastolic

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522014
mm[Hg]
Vital Signs - Erect Heart Rate
Beschreibung

Vital Signs - Erect Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522014
beats/min
12 Lead ECG Monitoring
Beschreibung

12 Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
12 Lead ECG Monitoring - Date
Beschreibung

12 Lead ECG Monitoring - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
12 Lead ECG Monitoring - Actual Time
Beschreibung

12 Lead ECG Monitoring - Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0040223
12 Lead ECG Monitoring - Heart Rate
Beschreibung

12 Lead ECG Monitoring - Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
12 Lead ECG Monitoring - PR
Beschreibung

12 Lead ECG Monitoring - PR

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
ms
12 Lead ECG Monitoring - QRS
Beschreibung

12 Lead ECG Monitoring - QRS

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
ms
12 Lead ECG Monitoring - QTC
Beschreibung

12 Lead ECG Monitoring - QTC

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0489625
ms
12 Lead ECG Monitoring - ECG clinically significant?
Beschreibung

12 Lead ECG Monitoring - ECG clinically significant?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2826293
12 Lead ECG Monitoring - Comments
Beschreibung

12 Lead ECG Monitoring - Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0947611
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Ähnliche Modelle

Smoking History; RLS Pharmacotherapy History; Vital Signs; 12 Lead ECG Monitoring

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient administration
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Smoking History (Screening)
C1519384 (UMLS CUI-1)
Is the subject a smoker?
Item
Is the subject a smoker?
boolean
C1519386 (UMLS CUI [1])
Number of years the subject has been a smoker?
Item
Number of years the subject has been a smoker?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Average number of cigarettes smoked per day?
Item
Average number of cigarettes smoked per day?
integer
C1608325 (UMLS CUI [1])
Please state what type of tobacco product (eg. pipe, cigar, chewing tobacco or cigarette)
Item
Please state what type of tobacco product (eg. pipe, cigar, chewing tobacco or cigarette)
text
C3166496 (UMLS CUI [1])
C0678447 (UMLS CUI [2])
C0678446 (UMLS CUI [3])
C0241410 (UMLS CUI [4])
C0677453 (UMLS CUI [5])
Item Group
RLS Pharmacotherapy History (Screening)
C0013216 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
Has the patient taken any pharmacotherapy medication for treatment of RLS?
Item
Has the patient taken any pharmacotherapy medication for treatment of RLS?
boolean
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
RLS Pharmacotherapy History (Screening)
C0013216 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS Pharmacotherapy - Drug Name
Item
RLS Pharmacotherapy - Drug Name
text
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C2360065 (UMLS CUI [2])
RLS Pharmacotherapy - Start Date
Item
RLS Pharmacotherapy - Start Date
date
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
RLS Pharmacotherapy - End date
Item
RLS Pharmacotherapy - End date
date
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
RLS Pharmacotherapy - Continuing
integer
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
RLS Pharmacotherapy - Continuing
Code List
RLS Pharmacotherapy - Continuing
CL Item
Continuing (1)
Item
RLS Pharmacotherapy - Did the patient respond to the treatment?
text
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0521982 (UMLS CUI [2])
RLS Pharmacotherapy - Did the patient respond to the treatment?
Code List
RLS Pharmacotherapy - Did the patient respond to the treatment?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (Unk)
Item
RLS Pharmacotherapy - Did the patient tolerate the treatment?
text
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0013220 (UMLS CUI [2])
RLS Pharmacotherapy - Did the patient tolerate the treatment?
Code List
RLS Pharmacotherapy - Did the patient tolerate the treatment?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (Unk)
Item Group
Vital Signs (Screening)
C0518766 (UMLS CUI-1)
Vital Signs - Date and Time
Item
Vital Signs - Date and Time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Vital Signs - Semi-supine BP Systolic
Item
Vital Signs - Semi-supine BP Systolic
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Semi-supine BP Diastolic
Item
Vital Signs - Semi-supine BP Diastolic
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Semi-supine Hear Rate
Item
Vital Signs - Semi-supine Hear Rate
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Time
Item
Vital Signs - Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Vital Signs - Erect BP Systolic
Item
Vital Signs - Erect BP Systolic
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Vital Signs - Erect BP Diastolic
Item
Vital Signs - Erect BP Diastolic
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Vital Signs - Erect Heart Rate
Item
Vital Signs - Erect Heart Rate
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Item Group
12 Lead ECG Monitoring
C0430456 (UMLS CUI-1)
12 Lead ECG Monitoring - Date
Item
12 Lead ECG Monitoring - Date
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 Lead ECG Monitoring - Actual Time
Item
12 Lead ECG Monitoring - Actual Time
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
12 Lead ECG Monitoring - Heart Rate
Item
12 Lead ECG Monitoring - Heart Rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 Lead ECG Monitoring - PR
Item
12 Lead ECG Monitoring - PR
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 Lead ECG Monitoring - QRS
Item
12 Lead ECG Monitoring - QRS
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 Lead ECG Monitoring - QTC
Item
12 Lead ECG Monitoring - QTC
integer
C0430456 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
12 Lead ECG Monitoring - ECG clinically significant?
Item
12 Lead ECG Monitoring - ECG clinically significant?
boolean
C0430456 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
12 Lead ECG Monitoring - Comments
Item
12 Lead ECG Monitoring - Comments
text
C0430456 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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