ID

36393

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 concomitant medication form. It has to be filled in if the subject takes concomitant medication during the study.

Palabras clave

Versiones (2)
  1. 5/9/17 5/9/17 -
  2. 10/5/19 10/5/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

10 de mayo 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

Concomitant Medication

1 formularios  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
CONCOMITANT MEDICATION
Descripción

CONCOMITANT MEDICATION

Alias
UMLS CUI-1
C2347852
Are there any concomitant medication changes since the start of the study?
Descripción

If ‘Yes’, please record all medications below. When appropriate, medical conditions should be recorded on the Adverse Event form, utilising the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.

Tipo de datos

text

Alias
UMLS CUI [1]
C2347852
Drug Name
Descripción

(Trade name preferred)

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Single dose/Unit
Descripción

Single dose/unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1960417
Frequency of this dose
Descripción

dose frequency

Tipo de datos

text

Alias
UMLS CUI [1]
C2826654
Route
Descripción

Route

Tipo de datos

text

Alias
UMLS CUI [1]
C0013153
Indication
Descripción

Indication

Tipo de datos

text

Alias
UMLS CUI [1]
C3146298
Start Date
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013227
Start Time
Descripción

00.00-23:59

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0013227
End Date
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
End Time
Descripción

00:00-23:59

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0013227
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Similar models

Concomitant Medication

1 formularios
  1. StudyEvent: ODM
    1. Concomitant Medication
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
CONCOMITANT MEDICATION
C2347852 (UMLS CUI-1)
Item
Are there any concomitant medication changes since the start of the study?
text
C2347852 (UMLS CUI [1])
Concomitant Medication
Code List
Are there any concomitant medication changes since the start of the study?
CL Item
Yes (Y)
CL Item
No (N)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Single dose/unit
Item
Single dose/Unit
text
C1960417 (UMLS CUI [1])
dose frequency
Item
Frequency of this dose
text
C2826654 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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