ID

36393

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

Keywords

Versions (2)
  1. 9/5/17 9/5/17 -
  2. 5/10/19 5/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 10, 2019

DOI

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License

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

English

Concomitant Medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
CONCOMITANT MEDICATION
Description

CONCOMITANT MEDICATION

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

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.

Data type

text

Alias
UMLS CUI [1]
C2347852
Drug Name
Description

(Trade name preferred)

Data type

text

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

Single dose/unit

Data type

text

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

dose frequency

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Indication
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Start Date
Description

day month year

Data type

date

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

00.00-23:59

Data type

time

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

day month year

Data type

date

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

00:00-23:59

Data type

time

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

Concomitant Medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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