ID

40792

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

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Versions (1)
  1. 5/14/20 5/14/20 -
Copyright Holder

GlaxoSmithKline

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May 14, 2020

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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

English

Diary Card Week 1, Diary Card Week X

1 forms  
Administrative
Description

Administrative

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
Investigator
Description

Investigator

Data type

text

Alias
UMLS CUI [1]
C2826892
Location
Description

Location

Data type

text

Alias
UMLS CUI [1]
C0450429
Contact Tel No
Description

Contact Tel No

Data type

integer

Alias
UMLS CUI [1]
C1515258
Diary Card Week 1
Description

Diary Card Week 1

Alias
UMLS CUI-1
C3890583
DayNo
Description

Day No

Data type

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0237753
Date
Description

Date

Data type

datetime

Alias
UMLS CUI [1]
C0011008
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Symptoms Week 1
Description

Symptoms Week 1

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0439230
Symptom
Description

Symptom

Data type

text

Alias
UMLS CUI [1]
C1457887
Symptom Start date & time
Description

Symptom Start date & time

Data type

datetime

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Symptom Stop date & time
Description

Symptom Stop date & time

Data type

datetime

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Actigraphy and sleep EEG recording - Week 1 Dose Level = 2
Description

Actigraphy and sleep EEG recording - Week 1 Dose Level = 2

Alias
UMLS CUI-1
C1171301
UMLS CUI-2
C0013819
UMLS CUI-3
C0037313
UMLS CUI-4
C0439230
UMLS CUI-5
C0178602
Actigraphy and sleep EEG - Date before taking dose level 1 medication
Description

Please enter the dates of the 2 nights when recordings were made before taking dose level 1 medication.

Data type

date

Alias
UMLS CUI [1,1]
C1171301
UMLS CUI [1,2]
C0013819
UMLS CUI [1,3]
C0037313
UMLS CUI [2]
C0011008
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0332152
Actigraphy and sleep EEG - Date before taking dose level 1 medication
Description

Please enter the dates of the 2 nights when recordings were made before taking dose level 1 medication.

Data type

date

Alias
UMLS CUI [1,1]
C1171301
UMLS CUI [1,2]
C0013819
UMLS CUI [1,3]
C0037313
UMLS CUI [2]
C0011008
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0332152
Actigraphy and sleep EEG - Date
Description

Please enter the dates of the 2 nights when the actigraphy and EEG recordings were made.

Data type

date

Alias
UMLS CUI [1,1]
C1171301
UMLS CUI [1,2]
C0013819
UMLS CUI [1,3]
C0037313
UMLS CUI [2]
C0011008
Actigraphy and sleep EEG - Date
Description

Please enter the dates of the 2 nights when the actigraphy and EEG recordings were made.

Data type

date

Alias
UMLS CUI [1,1]
C1171301
UMLS CUI [1,2]
C0013819
UMLS CUI [1,3]
C0037313
UMLS CUI [2]
C0011008
Diary Card Week X
Description

Diary Card Week X

Alias
UMLS CUI-1
C3890583
Week No
Description

Week No

Data type

integer

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0237753
Dose Level
Description

Dose Level

Data type

integer

Alias
UMLS CUI [1]
C0178602
Day No
Description

Day No

Data type

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0237753
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Symptoms Week X
Description

Symptoms Week X

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0439230
Week No
Description

Week No

Data type

integer

Alias
UMLS CUI [1]
C0439230
Symptom
Description

Symptom

Data type

text

Alias
UMLS CUI [1]
C1457887
Symptom Start date & time
Description

Symptom Start date & time

Data type

datetime

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Symptom Stop date & time
Description

Symptom Stop date & time

Data type

datetime

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Actigraphy and sleep EEG recording - Week X Dose Level = X
Description

Actigraphy and sleep EEG recording - Week X Dose Level = X

Alias
UMLS CUI-1
C1171301
UMLS CUI-2
C0013819
UMLS CUI-3
C0037313
UMLS CUI-4
C0439230
UMLS CUI-5
C0178602
Week No
Description

Week No

Data type

integer

Alias
UMLS CUI [1]
C0439230
Dose Level
Description

Dose Level

Data type

integer

Alias
UMLS CUI [1]
C0178602
Actigraphy and sleep EEG - Date
Description

Please enter the dates of the 2 nights when the actigraphy and EEG recordings were made.

Data type

date

Alias
UMLS CUI [1,1]
C1171301
UMLS CUI [1,2]
C0013819
UMLS CUI [1,3]
C0037313
UMLS CUI [2]
C0011008
Actigraphy and sleep EEG - Date
Description

Please enter the dates of the 2 nights when the actigraphy and EEG recordings were made.

Data type

date

Alias
UMLS CUI [1,1]
C1171301
UMLS CUI [1,2]
C0013819
UMLS CUI [1,3]
C0037313
UMLS CUI [2]
C0011008
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Similar models

Diary Card Week 1, Diary Card Week X

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
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])
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Location
Item
Location
text
C0450429 (UMLS CUI [1])
Contact Tel No
Item
Contact Tel No
integer
C1515258 (UMLS CUI [1])
Item Group
Diary Card Week 1
C3890583 (UMLS CUI-1)
Day No
Item
DayNo
integer
C0439228 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date
Item
Date
datetime
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item Group
Symptoms Week 1
C1457887 (UMLS CUI-1)
C0439230 (UMLS CUI-2)
Symptom
Item
Symptom
text
C1457887 (UMLS CUI [1])
Symptom Start date & time
Item
Symptom Start date & time
datetime
C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Symptom Stop date & time
Item
Symptom Stop date & time
datetime
C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item Group
Actigraphy and sleep EEG recording - Week 1 Dose Level = 2
C1171301 (UMLS CUI-1)
C0013819 (UMLS CUI-2)
C0037313 (UMLS CUI-3)
C0439230 (UMLS CUI-4)
C0178602 (UMLS CUI-5)
Actigraphy and sleep EEG - Date before taking dose level 1 medication
Item
Actigraphy and sleep EEG - Date before taking dose level 1 medication
date
C1171301 (UMLS CUI [1,1])
C0013819 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
C0178602 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
Actigraphy and sleep EEG - Date before taking dose level 1 medication
Item
Actigraphy and sleep EEG - Date before taking dose level 1 medication
date
C1171301 (UMLS CUI [1,1])
C0013819 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
C0178602 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
Actigraphy and sleep EEG - Date
Item
Actigraphy and sleep EEG - Date
date
C1171301 (UMLS CUI [1,1])
C0013819 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
Actigraphy and sleep EEG - Date
Item
Actigraphy and sleep EEG - Date
date
C1171301 (UMLS CUI [1,1])
C0013819 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
Item Group
Diary Card Week X
C3890583 (UMLS CUI-1)
Week No
Item
Week No
integer
C0439230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Dose Level
Item
Dose Level
integer
C0178602 (UMLS CUI [1])
Day No
Item
Day No
integer
C0439228 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item Group
Symptoms Week X
C1457887 (UMLS CUI-1)
C0439230 (UMLS CUI-2)
Week No
Item
Week No
integer
C0439230 (UMLS CUI [1])
Symptom
Item
Symptom
text
C1457887 (UMLS CUI [1])
Symptom Start date & time
Item
Symptom Start date & time
datetime
C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Symptom Stop date & time
Item
Symptom Stop date & time
datetime
C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item Group
Actigraphy and sleep EEG recording - Week X Dose Level = X
C1171301 (UMLS CUI-1)
C0013819 (UMLS CUI-2)
C0037313 (UMLS CUI-3)
C0439230 (UMLS CUI-4)
C0178602 (UMLS CUI-5)
Week No
Item
Week No
integer
C0439230 (UMLS CUI [1])
Dose Level
Item
Dose Level
integer
C0178602 (UMLS CUI [1])
Actigraphy and sleep EEG - Date
Item
Actigraphy and sleep EEG - Date
date
C1171301 (UMLS CUI [1,1])
C0013819 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
Actigraphy and sleep EEG - Date
Item
Actigraphy and sleep EEG - Date
date
C1171301 (UMLS CUI [1,1])
C0013819 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
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