ID

40731

Descripción

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

Palabras clave

Versiones (2)
  1. 5/5/20 5/5/20 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5 de mayo de 2020

DOI

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Licencia

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

Inglés

Prior Medication

1 formularios  
  1. StudyEvent: ODM
    1. Prior Medication
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Descripción

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Descripción

Centre Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Prior Medication
Descripción

Prior Medication

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

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

Tipo de datos

boolean

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

Prior Medication

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

Trade Name Preferred

Tipo de datos

text

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

e.g.500mg

Tipo de datos

text

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

e.g.BID,PRN

Tipo de datos

text

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

Prior Medication - Route

Tipo de datos

text

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

Prior Medication - Indication

Tipo de datos

text

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

eg.6 years

Tipo de datos

text

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

Prior Medication - End Date

Tipo de datos

date

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

Prior Medication - Continuing at end of study?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C1553904
UMLS CUI [1,3]
C2983670
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Similar models

Prior Medication

1 formularios
  1. StudyEvent: ODM
    1. Prior Medication
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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