ID
36895
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 AE/ Concomitant Medication Probe form. It has to be filled in for each study day (Day1-Day19) and for Follow-up.
Nyckelord
Versioner (2)
- 2017-09-02 2017-09-02 -
- 2019-06-19 2019-06-19 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
19 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
AE/ Concomitant Medication Probe
- StudyEvent: ODM
Beskrivning
AE, Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Note: Pre-dose only is to be queried for Day 1. Timing +24 hrs is to be queried prior to next dose. For Follow-up: There is no specific time.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0178602
Beskrivning
If you tick no, please comment in the item "Comment".
Datatyp
text
Alias
- UMLS CUI [1]
- C0566217
Beskrivning
Fill in if subject was not asked.
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
AE/ Concomitant Medication Probe
- StudyEvent: ODM
C0178602 (UMLS CUI [1,2])