ID

40755

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

  1. 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

PK Blood Sampling

  1. StudyEvent: ODM
    1. PK Blood Sampling
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject 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
PK Blood Sampling
Description

PK Blood Sampling

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031327
Time relative to start of dose
Description

Time relative to start of dose

Data type

integer

Alias
UMLS CUI [1]
C0040223
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C0439659
PK Blood Sampling - Date
Description

PK Blood Sampling - Date

Data type

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031327
UMLS CUI [2]
C0011008
PK Blood Sampling - Actual Time
Description

PK Blood Sampling - Actual Time

Data type

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031327
UMLS CUI [2]
C0040223
PK Blood Sample Taken?
Description

PK Blood Sample Taken?

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031327
PK Blood Sampling
Description

PK Blood Sampling

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031327
UMLS CUI [2]
C0947611

Similar models

PK Blood Sampling

  1. StudyEvent: ODM
    1. PK Blood Sampling
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
PK Blood Sampling
C0005834 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
Item
Time relative to start of dose
integer
C0040223 (UMLS CUI [1])
C3174092 (UMLS CUI [2,1])
C0439659 (UMLS CUI [2,2])
Code List
Time relative to start of dose
CL Item
Pre-dose (1)
CL Item
+0.25 hrs (2)
CL Item
+0.5 hrs (3)
CL Item
+1 hr (4)
CL Item
+1.5 hrs (5)
CL Item
+2 hrs (6)
CL Item
+3 hrs (7)
CL Item
+4 hrs (8)
CL Item
+6 hrs (9)
CL Item
+8 hrs (10)
CL Item
+12 hrs (11)
CL Item
+24 hrs (12)
PK Blood Sampling - Date
Item
PK Blood Sampling - Date
datetime
C0005834 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
PK Blood Sampling - Actual Time
Item
PK Blood Sampling - Actual Time
time
C0005834 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
PK Blood Sample Taken?
Item
PK Blood Sample Taken?
boolean
C0005834 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
PK Blood Sampling
Item
PK Blood Sampling
text
C0005834 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])

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