ID

44323

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. 27/4/20 27/4/20 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de septiembre de 2021

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

Dose Level 1, Day1, Pre-dose - Prior Medication; Pregnancy Test; Alcohol Breath Test; Drug Screening (Urine); Vital Signs

1 formularios  
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]
C0444921
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
Pregnancy Test
Descripción

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Was a pregnancy test carried out?
Descripción

Was a pregnancy test carried out?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032976
If no pregnancy test was carried out, please specify reason
Descripción

If no pregnancy test was carried out, please specify reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C2826287
Date of pregnancy test
Descripción

Date of pregnancy test

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy test result
Descripción

Pregnancy test result

Tipo de datos

integer

Alias
UMLS CUI [1]
C0427777
Alcohol Breath Test
Descripción

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Was an alcohol breath test carried out?
Descripción

Was an alcohol breath test carried out?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202306
If no alcohol breath test was carried out, specify reason
Descripción

If no alcohol breath test was carried out, specify reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C2826287
If alcohol breath test was carried out, indicate date of alcohol breath test
Descripción

If alcohol breath test was carried out, indicate date of alcohol breath test

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C001100
Alcohol breath test result
Descripción

Alcohol breath test result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0587081
Drug Screening (Urine)
Descripción

Drug Screening (Urine)

Alias
UMLS CUI-1
C0202274
Drug Screening (Urine) - Exact date end time of sampling
Descripción

Drug Screening (Urine) - Exact date end time of sampling

Tipo de datos

datetime

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2,1]
C0870078
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Were there any contra-indicated drugs detected?
Descripción

If YES, please record all the relevant contra-indicated drugs below.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C4036061
UMLS CUI [1,3]
C1301624
Drug Screening (Urine) - Type of drug
Descripción

Drug Screening (Urine) - Type of drug

Tipo de datos

text

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2]
C0457591
Drug Screening (Urine) - Comment
Descripción

Drug Screening (Urine) - Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2]
C0947611
Vital Signs
Descripción

Vital Signs

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

Vital Signs - Date and Time

Tipo de datos

datetime

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

Vital Signs - Semi-supine BP Systolic

Tipo de datos

integer

Unidades de medida
  • 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
Descripción

Vital Signs - Semi-supine BP Diastolic

Tipo de datos

integer

Unidades de medida
  • 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
Descripción

Vital Signs - Semi-supine Hear Rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522019
beats/min
Vital Signs - Time
Descripción

Vital Signs - Time

Tipo de datos

time

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

Vital Signs - Erect BP Systolic

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522014
mm[Hg]
Vital Signs - Erect BP Diastolic
Descripción

Vital Signs - Erect BP Diastolic

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522014
mm[Hg]
Vital Signs - Erect Heart Rate
Descripción

Vital Signs - Erect Heart Rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522014
beats/min
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Similar models

Dose Level 1, Day1, Pre-dose - Prior Medication; Pregnancy Test; Alcohol Breath Test; Drug Screening (Urine); Vital Signs

1 formularios
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])
C0444921 (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])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Was a pregnancy test carried out?
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
If no pregnancy test was carried out, please specify reason
Item
If no pregnancy test was carried out, please specify reason
text
C0032976 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test result
integer
C0427777 (UMLS CUI [1])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
Was an alcohol breath test carried out?
Item
Was an alcohol breath test carried out?
boolean
C0202306 (UMLS CUI [1])
If no alcohol breath test was carried out, specify reason
Item
If no alcohol breath test was carried out, specify reason
text
C0202306 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
If alcohol breath test was carried out, indicate date of alcohol breath test
Item
If alcohol breath test was carried out, indicate date of alcohol breath test
date
C0202306 (UMLS CUI [1,1])
C001100 (UMLS CUI [1,2])
Item
Alcohol breath test result
integer
C0202306 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Alcohol breath test result
Code List
Alcohol breath test result
CL Item
Positive  (1)
CL Item
Negative (2)
Item Group
Drug Screening (Urine)
C0202274 (UMLS CUI-1)
Drug Screening (Urine) - Exact date end time of sampling
Item
Drug Screening (Urine) - Exact date end time of sampling
datetime
C0202274 (UMLS CUI [1])
C0870078 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Were there any contra-indicated drugs detected?
Item
Were there any contra-indicated drugs detected?
boolean
C1511790 (UMLS CUI [1,1])
C4036061 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
Drug Screening (Urine) - Type of drug
Item
Drug Screening (Urine) - Type of drug
text
C0202274 (UMLS CUI [1])
C0457591 (UMLS CUI [2])
Drug Screening (Urine) - Comment
Item
Drug Screening (Urine) - Comment
text
C0202274 (UMLS CUI [1])
C0947611 (UMLS CUI [2])
Item Group
Vital Signs
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])
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