ID

36910

Beskrivning

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.

Nyckelord

Versioner (1)
  1. 2019-06-21 2019-06-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21 juni 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

Engelsk

Unscheduled measurements

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

integer

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

Clinical chemistry and haematology

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

day month year

Datatyp

date

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

00:00-23:59

Datatyp

time

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

Comments

Datatyp

text

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

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

Datatyp

text

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

Urinalysis

Alias
UMLS CUI-1
C0042014
Date of urine sampling
Beskrivning

day month year

Datatyp

date

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

00:00-23:59

Datatyp

time

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

Comments

Datatyp

text

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

laboratory findings urinalysis

Datatyp

boolean

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

Drug Screening (Urine)

Alias
UMLS CUI-1
C0202274
Date of urine sampling
Beskrivning

day month year

Datatyp

date

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

00:00-23:59

Datatyp

time

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

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

Datatyp

text

Alias
UMLS CUI [1]
C3845816
Type of drug
Beskrivning

Type of drug

Datatyp

text

Alias
UMLS CUI [1]
C0457591
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Study day
Beskrivning

Study day

Datatyp

integer

Alias
UMLS CUI [1]
C2826182
Study time
Beskrivning

Study time

Datatyp

integer

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

Position at measurement

Datatyp

integer

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

day month year

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Time of measurement
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Beskrivning

Pulse

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12 Lead ECG
Beskrivning

12 Lead ECG

Alias
UMLS CUI-1
C0430456
Study day
Beskrivning

Study day

Datatyp

integer

Alias
UMLS CUI [1]
C2826182
Study time
Beskrivning

Study time

Datatyp

integer

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

day month year

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Time of measurement
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Beskrivning

PR

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Beskrivning

QRS

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT
Beskrivning

QT

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Beskrivning

QTc

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Beskrivning

ECG normal

Datatyp

text

Alias
UMLS CUI [1]
C0522054
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
General Comments
Beskrivning

General Comments

Alias
UMLS CUI-1
C0947611
General Comments
Beskrivning

General Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Tillbaka till toppen

Similar models

Unscheduled measurements

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial