ID

36911

Beschrijving

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Unscheduled measurements form. It includes: Laboratory, Drug Screening, Vital Signs, 12 Lead ECG and General comments. It has to be filled in if required.

Trefwoorden

Versies (2)
  1. 05-09-17 05-09-17 -
  2. 21-06-19 21-06-19 -
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GlaxoSmithKline

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21 juni 2019

DOI

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Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Engels

Unscheduled measurements

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Clinical chemistry and haematology
Beschrijving

Clinical chemistry and haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Date of blood sampling
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
Time of blood sampling
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0005834
Comments:
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beschrijving

If ‘Yes’, please record diagnosis on Adverse Event page.

Datatype

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0005834
Urinalysis
Beschrijving

Urinalysis

Alias
UMLS CUI-1
C0042014
Date of urine sampling
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200354
Time of urine sampling
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200354
Comments:
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beschrijving

laboratory findings urinalysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0042014
Drug Screening (Urine)
Beschrijving

Drug Screening (Urine)

Alias
UMLS CUI-1
C0202274
Date of urine sampling
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200354
Time of urine sampling
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200354
Were there any contra-indicated drugs detected?
Beschrijving

If ‘Yes’, please record all the relevant contra-indicated drugs below.

Datatype

text

Alias
UMLS CUI [1]
C3845816
Type of drug
Beschrijving

Type of drug

Datatype

text

Alias
UMLS CUI [1]
C0457591
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Vital signs
Beschrijving

Vital signs

Alias
UMLS CUI-1
C0518766
Study day
Beschrijving

Study day

Datatype

integer

Alias
UMLS CUI [1]
C2826182
Study time
Beschrijving

Study time

Datatype

integer

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Position at measurement
Beschrijving

Position at measurement

Datatype

integer

Alias
UMLS CUI [1,1]
C2963216
UMLS CUI [1,2]
C1262869
Date of measurement
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
Time of measurement
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Beschrijving

Systolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12 Lead ECG
Beschrijving

12 Lead ECG

Alias
UMLS CUI-1
C0430456
Study day
Beschrijving

Study day

Datatype

integer

Alias
UMLS CUI [1]
C2826182
Study time
Beschrijving

Study time

Datatype

integer

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date of measurement
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
Time of measurement
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Beschrijving

PR

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Beschrijving

QRS

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT
Beschrijving

QT

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Beschrijving

QTc

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Beschrijving

ECG normal

Datatype

text

Alias
UMLS CUI [1]
C0522054
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
General Comments
Beschrijving

General Comments

Alias
UMLS CUI-1
C0947611
General Comments
Beschrijving

General Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Unscheduled measurements

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Clinical chemistry and haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date of blood sampling
Item
Date of blood sampling
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Time of blood sampling
Item
Time of blood sampling
time
C0040223 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
text
C0022877 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
laboratory findings blood sampling
Code List
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Date of urine sampling
Item
Date of urine sampling
date
C0011008 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Time of urine sampling
Item
Time of urine sampling
time
C0040223 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
laboratory findings urinalysis
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C0022877 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Item Group
Drug Screening (Urine)
C0202274 (UMLS CUI-1)
Date of urine sampling
Item
Date of urine sampling
date
C0011008 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Time of urine sampling
Item
Time of urine sampling
time
C0040223 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Item
Were there any contra-indicated drugs detected?
text
C3845816 (UMLS CUI [1])
Contraindicated drugs
Code List
Were there any contra-indicated drugs detected?
CL Item
Yes (Y)
CL Item
No (N)
Type of drug
Item
Type of drug
text
C0457591 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Study day
Item
Study day
integer
C2826182 (UMLS CUI [1])
Study time
Item
Study time
integer
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Position at measurement
integer
C2963216 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Position at measurement
Code List
Position at measurement
CL Item
Supine (1)
CL Item
Standing (2)
Date of measurement
Item
Date of measurement
date
C0011008 (UMLS CUI [1])
Time of measurement
Item
Time of measurement
time
C0040223 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
12 Lead ECG
C0430456 (UMLS CUI-1)
Study day
Item
Study day
integer
C2826182 (UMLS CUI [1])
Study time
Item
Study time
integer
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of measurement
Item
Date of measurement
date
C0011008 (UMLS CUI [1])
Time of measurement
Item
Time of measurement
time
C0040223 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
integer
C0429087 (UMLS CUI [1])
QRS
Item
QRS
integer
C0429025 (UMLS CUI [1])
QT
Item
QT
integer
C1287082 (UMLS CUI [1])
QTc
Item
QTc
integer
C0489625 (UMLS CUI [1])
Item
ECG normal?
text
C0522054 (UMLS CUI [1])
ECG normal
Code List
ECG normal?
CL Item
Yes (Y)
CL Item
No (N)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
General Comments
C0947611 (UMLS CUI-1)
General Comments
Item
General Comments
text
C0947611 (UMLS CUI [1])
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