ID

36873

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 Eligibility Review. It has to be filled in prior to dosing Day 1.

Keywords

  1. 9/1/17 9/1/17 -
  2. 6/18/19 6/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 18, 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

Eligibility Review

  1. StudyEvent: ODM
    1. Eligibility Review
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Description

Volunteer panel number

Data type

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Eligibility Review
Description

Eligibility Review

Alias
UMLS CUI-1
C0013893
UMLS CUI-2
C3166277
Has subject met all inclusion/exclusion criteria?
Description

If you tick No, please comment in the Item "Comment".

Data type

text

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C3166277
Is subject suitable for inclusion?
Description

If you tick No, please comment in the Item "Comment".

Data type

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0332149
Is subject included?
Description

If you tick No, please comment in the Item "Comment".

Data type

text

Alias
UMLS CUI [1]
C2348568
Comment
Description

Fill in if you ticked "No" in prior items.

Data type

text

Alias
UMLS CUI [1]
C0947611
Investigator
Description

Investigator

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008

Similar models

Eligibility Review

  1. StudyEvent: ODM
    1. Eligibility Review
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Volunteer panel number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Eligibility Review
C0013893 (UMLS CUI-1)
C3166277 (UMLS CUI-2)
Item
Has subject met all inclusion/exclusion criteria?
text
C0013893 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
Code List
Has subject met all inclusion/exclusion criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is subject suitable for inclusion?
text
C1512693 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Code List
Is subject suitable for inclusion?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is subject included?
text
C2348568 (UMLS CUI [1])
Code List
Is subject included?
CL Item
Yes (Y)
CL Item
No (N)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])

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