ID
36909
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 Laboratory Collections, Urinalaysis and Pregnancy test for follow-up form. It has to be filled in at Follow-up.
Nyckelord
Versioner (2)
- 2017-09-05 2017-09-05 -
- 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.
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
Laboratory Collections, Urinalaysis, Pregnancy test follow-up
- StudyEvent: ODM
Beskrivning
Laboratory Collection - Clinical chemistry and haematology
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C0018941
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
If ‘Yes’, please record diagnosis on Adverse Event page.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [2,1]
- C0018941
- UMLS CUI [2,2]
- C0243095
Beskrivning
Laboratory Collection - Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0022877
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
If ‘Yes’, please record diagnosis on Adverse Event page.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0243095
Beskrivning
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Beskrivning
Pregnancy test performance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518965
- UMLS CUI [1,2]
- C0032976
Beskrivning
No test performance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0032976
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0032976
Beskrivning
Pregnancy test result
Datatyp
text
Alias
- UMLS CUI [1]
- C0427777
Beskrivning
Pregnancy test type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0332307
Beskrivning
Other Pregnancy test type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0032976
- UMLS CUI [1,3]
- C0332307
Beskrivning
Ensure result is included on laboratory report
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Similar models
Laboratory Collections, Urinalaysis, Pregnancy test follow-up
- StudyEvent: ODM
C0008000 (UMLS CUI-2)
C0018941 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0243095 (UMLS CUI [2,2])
C0022877 (UMLS CUI-2)
C0200345 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])