ID

44323

Beschrijving

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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Versies (2)
  1. 27-04-20 27-04-20 -
  2. 20-09-21 20-09-21 -
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GlaxoSmithKline

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20 september 2021

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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

Engels

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

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschrijving

Centre Number

Datatype

text

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

Prior Medication

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

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

Datatype

boolean

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

Prior Medication

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

Trade Name Preferred

Datatype

text

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

e.g.500mg

Datatype

text

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

e.g.BID,PRN

Datatype

text

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

Prior Medication - Route

Datatype

text

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

Prior Medication - Indication

Datatype

text

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

eg.6 years

Datatype

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0444921
Prior Medication - End Date
Beschrijving

Prior Medication - End Date

Datatype

date

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

Prior Medication - Continuing at end of study?

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C1553904
UMLS CUI [1,3]
C2983670
Pregnancy Test
Beschrijving

Pregnancy Test

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

Was a pregnancy test carried out?

Datatype

boolean

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

If no pregnancy test was carried out, please specify reason

Datatype

text

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

Date of pregnancy test

Datatype

date

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

Pregnancy test result

Datatype

integer

Alias
UMLS CUI [1]
C0427777
Alcohol Breath Test
Beschrijving

Alcohol Breath Test

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

Was an alcohol breath test carried out?

Datatype

boolean

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

If no alcohol breath test was carried out, specify reason

Datatype

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
Beschrijving

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

Datatype

date

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

Alcohol breath test result

Datatype

integer

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

Drug Screening (Urine)

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

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

Datatype

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?
Beschrijving

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

Datatype

boolean

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

Drug Screening (Urine) - Type of drug

Datatype

text

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

Drug Screening (Urine) - Comment

Datatype

text

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

Vital Signs

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

Vital Signs - Date and Time

Datatype

datetime

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

Vital Signs - Semi-supine BP Systolic

Datatype

integer

Maateenheden
  • 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
Beschrijving

Vital Signs - Semi-supine BP Diastolic

Datatype

integer

Maateenheden
  • 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
Beschrijving

Vital Signs - Semi-supine Hear Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522019
beats/min
Vital Signs - Time
Beschrijving

Vital Signs - Time

Datatype

time

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

Vital Signs - Erect BP Systolic

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522014
mm[Hg]
Vital Signs - Erect BP Diastolic
Beschrijving

Vital Signs - Erect BP Diastolic

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522014
mm[Hg]
Vital Signs - Erect Heart Rate
Beschrijving

Vital Signs - Erect Heart Rate

Datatype

integer

Maateenheden
  • 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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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