ID

40731

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 (2)
  1. 05.05.20 05.05.20 -
  2. 20.09.21 20.09.21 -
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GlaxoSmithKline

Hochgeladen am

5. 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

Prior Medication

1 Formulare  
  1. StudyEvent: ODM
    1. Prior Medication
Administrative
Beschreibung

Administrative

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
Prior Medication
Beschreibung

Prior Medication

Alias
UMLS CUI-1
C2826257
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Beschreibung

If ’YES’, please record the medications below. NB: Any medications Metabolised by CYPIA2 must be kept constant throughout the study.

Datentyp

boolean

Alias
UMLS CUI [1]
C2826257
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C3174092
UMLS CUI [2,3]
C0205435
Prior Medication
Beschreibung

Prior Medication

Alias
UMLS CUI-1
C2826257
Prior Medication - Drug Name
Beschreibung

Trade Name Preferred

Datentyp

text

Alias
UMLS CUI [1]
C2826257
UMLS CUI [2]
C2360065
Prior Medication - Single Dose/ Unit
Beschreibung

e.g.500mg

Datentyp

text

Alias
UMLS CUI [1]
C2826257
UMLS CUI [2]
C1960417
Prior Medication - Frequency of this Dose
Beschreibung

e.g.BID,PRN

Datentyp

text

Alias
UMLS CUI [1]
C2826257
UMLS CUI [2]
C3476109
Prior Medication - Route
Beschreibung

Prior Medication - Route

Datentyp

text

Alias
UMLS CUI [1]
C2826257
UMLS CUI [2]
C0013153
Prior Medication - Indication
Beschreibung

Prior Medication - Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C3146298
Prior Medication - Duration of Therapy
Beschreibung

eg.6 years

Datentyp

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0444917
Prior Medication - End Date
Beschreibung

Prior Medication - End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0806020
Prior Medication - Continuing at end of study?
Beschreibung

Prior Medication - Continuing at end of study?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C1553904
UMLS CUI [1,3]
C2983670
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Ähnliche Modelle

Prior Medication

1 Formulare
  1. StudyEvent: ODM
    1. Prior Medication
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
boolean
C2826257 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Prior Medication - Drug Name
Item
Prior Medication - Drug Name
text
C2826257 (UMLS CUI [1])
C2360065 (UMLS CUI [2])
Prior Medication - Single Dose/ Unit
Item
Prior Medication - Single Dose/ Unit
text
C2826257 (UMLS CUI [1])
C1960417 (UMLS CUI [2])
Prior Medication - Frequency of this Dose
Item
Prior Medication - Frequency of this Dose
text
C2826257 (UMLS CUI [1])
C3476109 (UMLS CUI [2])
Item
Prior Medication - Route
text
C2826257 (UMLS CUI [1])
C0013153 (UMLS CUI [2])
Prior Medication - Route
Code List
Prior Medication - Route
CL Item
intra-articular (IA)
CL Item
intra-arterial (IAR)
CL Item
intra-dermal (ID)
CL Item
inhalation (IH)
CL Item
intra-muscular (IM)
CL Item
intra-thecal (IT)
CL Item
intra-venous (IV)
CL Item
nasal (NA)
CL Item
oral (PO)
CL Item
rectal (PR)
CL Item
subcutaneous (SC)
CL Item
sublingual (SL)
CL Item
transdermal (TD)
CL Item
topical (TO)
CL Item
vaginal (VA)
Prior Medication - Indication
Item
Prior Medication - Indication
text
C2826257 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Prior Medication - Duration of Therapy
Item
Prior Medication - Duration of Therapy
text
C2826257 (UMLS CUI [1,1])
C0444917 (UMLS CUI [1,2])
Prior Medication - End Date
Item
Prior Medication - End Date
date
C2826257 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Prior Medication - Continuing at end of study?
Item
Prior Medication - Continuing at end of study?
boolean
C2826257 (UMLS CUI [1,1])
C1553904 (UMLS CUI [1,2])
C2983670 (UMLS CUI [1,3])
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