ID

40759

Description

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

Keywords

Versions (3)
  1. 4/24/20 4/24/20 -
  2. 4/30/20 4/30/20 -
  3. 5/8/20 5/8/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 8, 2020

DOI

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License

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

English

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

1 forms  
Patient administration
Description

Patient administration

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

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

Visit Date

Data type

date

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

Smoking History (Screening)

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

If yes, please complete smoking history details.

Data type

boolean

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

Number of years the subject has been a smoker?

Data type

integer

Measurement units
  • 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?
Description

Average number of cigarettes smoked per day?

Data type

integer

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

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

Data type

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)
Description

RLS Pharmacotherapy History (Screening)

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

If yes, please record details below.

Data type

boolean

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

RLS Pharmacotherapy History (Screening)

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

Trade Name Preferred

Data type

text

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

be as precise as possible

Data type

date

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

RLS Pharmacotherapy - End date

Data type

date

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

RLS Pharmacotherapy - Continuing

Data type

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?
Description

RLS Pharmacotherapy - Did the patient respond to the treatment?

Data type

text

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

RLS Pharmacotherapy - Did the patient tolerate the treatment?

Data type

text

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

Vital Signs (Screening)

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

Vital Signs - Date and Time

Data type

datetime

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

Vital Signs - Semi-supine BP Systolic

Data type

integer

Measurement units
  • 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
Description

Vital Signs - Semi-supine BP Diastolic

Data type

integer

Measurement units
  • 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
Description

Vital Signs - Semi-supine Hear Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522019
beats/min
Vital Signs - Time
Description

Vital Signs - Time

Data type

time

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

Vital Signs - Erect BP Systolic

Data type

integer

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

Vital Signs - Erect BP Diastolic

Data type

integer

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

Vital Signs - Erect Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522014
beats/min
12 Lead ECG Monitoring
Description

12 Lead ECG Monitoring

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

12 Lead ECG Monitoring - Date

Data type

date

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

12 Lead ECG Monitoring - Actual Time

Data type

time

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

12 Lead ECG Monitoring - Heart Rate

Data type

integer

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

12 Lead ECG Monitoring - PR

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
ms
12 Lead ECG Monitoring - QRS
Description

12 Lead ECG Monitoring - QRS

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
ms
12 Lead ECG Monitoring - QTC
Description

12 Lead ECG Monitoring - QTC

Data type

integer

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

12 Lead ECG Monitoring - ECG clinically significant?

Data type

boolean

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

12 Lead ECG Monitoring - Comments

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0947611
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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