ID
36390
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 informed consent and demographic of subject form. It has to be filled in for screening.
Nyckelord
Versioner (2)
- 2017-08-31 2017-08-31 -
- 2019-05-10 2019-05-10 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
10 maj 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
Informed consent, Demography
- StudyEvent: ODM
Beskrivning
Informed Consent History
Alias
- UMLS CUI-1
- C0021430
Beskrivning
DEMOGRAPHY
Alias
- UMLS CUI-1
- C0011298
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Gender
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Race
Datatyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Other Race
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0034510
Beskrivning
Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Body mass index calculated using the following formula: Body Mass Index = ( Weight (kg) / (Height (cm) )² ) x 10,000
Datatyp
float
Måttenheter
- kg/m²
Alias
- UMLS CUI [1]
- C1305855
Beskrivning
Clinical Staff Signature
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0025106
- UMLS CUI [1,2]
- C1519316
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Informed consent, Demography
- StudyEvent: ODM
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0034510 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])