ID

36895

Descrição

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.

Palavras-chave

  1. 02/09/2017 02/09/2017 -
  2. 19/06/2019 19/06/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

19 de junho de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

AE/ Concomitant Medication Probe

Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Descrição

Subject number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Study Week
Descrição

Study Week

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0439230
Study Day
Descrição

Please note the study day: Day 1- Day 19, follow-up.

Tipo de dados

text

Unidades de medida
  • day
Alias
UMLS CUI [1]
C2826182
day
AE, Concomitant Medication
Descrição

AE, Concomitant Medication

Alias
UMLS CUI-1
C2347852
Time relative to start of dose
Descrição

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.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0178602
Subject asked
Descrição

If you tick no, please comment in the item "Comment".

Tipo de dados

text

Alias
UMLS CUI [1]
C0566217
Comment
Descrição

Fill in if subject was not asked.

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611

Similar models

AE/ Concomitant Medication Probe

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study Week
integer
C0008972 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Code List
Study Week
CL Item
Week 1 (1)
CL Item
Week 2 (2)
CL Item
Week 3 (3)
CL Item
Follow-up (4)
Study Day
Item
Study Day
text
C2826182 (UMLS CUI [1])
Item Group
AE, Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Time relative to start of dose
integer
C0040223 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Code List
Time relative to start of dose
CL Item
Pre-dose (1)
CL Item
+2 hrs (2)
CL Item
+6 hrs (3)
CL Item
+16 hrs (4)
CL Item
+24 hrs (5)
Item
Subject asked
text
C0566217 (UMLS CUI [1])
Code List
Subject asked
CL Item
Yes (Y)
CL Item
No (N)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial