ID

36085

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 (Day 0) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (Day 21) This document contains the prior medication form. It has to be filled in for screening.

Keywords

Versions (3)
  1. 4/15/19 4/15/19 -
  2. 4/15/19 4/15/19 -
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 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, 101468/201

English

Prior Medication

1 forms  
  1. StudyEvent: ODM
    1. Prior Medication
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Prior Medication
Description

Prior Medication

Alias
UMLS CUI-1
C2826257
Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
Description

If 'YES', please record the medications below.

Data type

boolean

Alias
UMLS CUI [1]
C3166216
UMLS CUI [2]
C0013231
DRUG NAME
Description

(Trade Name Preferred)

Data type

text

Alias
UMLS CUI [1]
C2360065
Single Dose/Unit (e.g.500 mg)
Description

Single Dose/Unit

Data type

text

Alias
UMLS CUI [1]
C1960417
Frequency of this Dose (e.g.BID, PR)
Description

Frequency of this Dose

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Indication
Description

Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Duration of therapy (e.g.6 years)
Description

Duration of therapy

Data type

text

Alias
UMLS CUI [1]
C0444917
End Date
Description

Day/Month/Year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuing at end of study?
Description

Continuing at end of study

Data type

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2983670
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Similar models

Prior Medication

1 forms
  1. StudyEvent: ODM
    1. Prior Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Prescribed or OTC medication
Item
Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
boolean
C3166216 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
DRUG NAME
Item
DRUG NAME
text
C2360065 (UMLS CUI [1])
Single Dose/Unit
Item
Single Dose/Unit (e.g.500 mg)
text
C1960417 (UMLS CUI [1])
Frequency of this Dose
Item
Frequency of this Dose (e.g.BID, PR)
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Duration of therapy
Item
Duration of therapy (e.g.6 years)
text
C0444917 (UMLS CUI [1])
End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Continuing at end of study
Item
Continuing at end of study?
boolean
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
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