ID
36910
Description
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.
Mots-clés
Versions (1)
- 21/06/2019 21/06/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
21 juin 2019
DOI
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Licence
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
Unscheduled measurements
- StudyEvent: ODM
Description
Clinical chemistry and haematology
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0018941
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0005834
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
If ‘Yes’, please record diagnosis on Adverse Event page.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0005834
Description
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200354
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200354
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
laboratory findings urinalysis
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0042014
Description
Drug Screening (Urine)
Alias
- UMLS CUI-1
- C0202274
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200354
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200354
Description
If ‘Yes’, please record all the relevant contra-indicated drugs below.
Type de données
text
Alias
- UMLS CUI [1]
- C3845816
Description
Type of drug
Type de données
text
Alias
- UMLS CUI [1]
- C0457591
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Vital signs
Alias
- UMLS CUI-1
- C0518766
Description
Study day
Type de données
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Study time
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
Description
Position at measurement
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
Systolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Pulse
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Heart rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
12 Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
Study day
Type de données
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Study time
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
Heart rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
PR
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
QT
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C1287082
Description
QTc
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0489625
Description
ECG normal
Type de données
text
Alias
- UMLS CUI [1]
- C0522054
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
General Comments
Alias
- UMLS CUI-1
- C0947611
Similar models
Unscheduled measurements
- StudyEvent: ODM
C0018941 (UMLS CUI-2)
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1262869 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])