ID

36913

Descripción

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 Physical Examination Follow- Up form. It has to be filled in at follow-up.

Palabras clave

Versiones (2)
  1. 5/9/17 5/9/17 -
  2. 21/6/19 21/6/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 de junio de 2019

DOI

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Licencia

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

Inglés

Physical Examination Follow- Up

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
PHYSICAL EXAMINATION
Descripción

PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0031809
Date
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Time
Descripción

00:00-23:59

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Has there been any change from the last examination (screening)?
Descripción

Physical Examination

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
If change form the last examination, please record here.
Descripción

Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
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Similar models

Physical Examination Follow- Up

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
PHYSICAL EXAMINATION
C0031809 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item
Has there been any change from the last examination (screening)?
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Physical Examination
Code List
Has there been any change from the last examination (screening)?
CL Item
Yes (Y)
CL Item
No (N)
Change in ohysical examination
Item
If change form the last examination, please record here.
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
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