ID

36913

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

Mots-clés

Versions (2)
  1. 05/09/2017 05/09/2017 -
  2. 21/06/2019 21/06/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

21 juin 2019

DOI

Pour une demande vous connecter.

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

Anglais

Physical Examination Follow- Up

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
PHYSICAL EXAMINATION
Description

PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0031809
Date
Description

day month year

Type de données

date

Alias
UMLS CUI [1]
C0011008
Time
Description

00:00-23:59

Type de données

time

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

Physical Examination

Type de données

text

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

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

Type de données

text

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

Physical Examination Follow- Up

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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