ID

36894

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 Dosing Details form. It has to be filled in for Week 1, Week 2 and Week 3.

Keywords

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

GlaxoSmithKline

Uploaded on

June 19, 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

Dosing Details

  1. StudyEvent: ODM
    1. Dosing Details
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Study Week
Description

Study Week

Data type

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0439230
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C1522508
Study Day
Description

Please note the study day: Day 1 - Day 19

Data type

integer

Measurement units
  • day
Alias
UMLS CUI [1]
C2826182
day
Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Dosing time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0178602
Dose checked and administered by:
Description

Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892

Similar models

Dosing Details

  1. StudyEvent: ODM
    1. Dosing Details
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
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)
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Study Day
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Dosing time
Item
Dosing time
time
C0040223 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Investigator's name
Item
Dose checked and administered by:
text
C2826892 (UMLS CUI [1])

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