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)
- 9/5/17 9/5/17 -
- 5/10/19 5/10/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 10, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201
Concomitant Medication
- StudyEvent: ODM
Description
CONCOMITANT MEDICATION
Alias
- UMLS CUI-1
- C2347852
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
Description
(Trade name preferred)
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Single dose/unit
Data type
text
Alias
- UMLS CUI [1]
- C1960417
Description
dose frequency
Data type
text
Alias
- UMLS CUI [1]
- C2826654
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Indication
Data type
text
Alias
- UMLS CUI [1]
- C3146298
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013227
Description
00.00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0013227
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0013227
Similar models
Concomitant Medication
- StudyEvent: ODM
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])