ID

36087

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 Drug Screening and Alcohol Breath Test for screening form. It has to be filled in for screening.

Keywords

Versions (2)
  1. 4/15/19 4/15/19 -
  2. 4/15/19 4/15/19 -
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

Drug Screening and Alcohol Breath Test for screening

1 forms  
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
Drug Screening
Description

Drug Screening

Alias
UMLS CUI-1
C0373483
Exact date of urine sampling
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
Exact time of urine sampling
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
Were there any contra-indicated drugs detected?
Description

If YES, please record all the relevant contra-indicated drugs below.

Data type

text

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C1254351
Type of drug
Description

Type of drug

Data type

text

Alias
UMLS CUI [1]
C0457591
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Alcohol breath test
Description

Alcohol breath test

Alias
UMLS CUI-1
C0202306
Exact date of test
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0011008
Exact time of test
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0429928
Result of Alcohol breath test
Description

Alcohol breath test result, tick one If POSITIVE, do not include the subject in the study.

Data type

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
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Similar models

Drug Screening and Alcohol Breath Test for screening

1 forms
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
Drug Screening
C0373483 (UMLS CUI-1)
Urine sampling date
Item
Exact date of urine sampling
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Urine sampling time
Item
Exact time of urine sampling
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Were there any contra-indicated drugs detected?
text
C1511790 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
Contra-indicated drugs detected
Code List
Were there any contra-indicated drugs detected?
CL Item
Yes (Y)
CL Item
No (N)
Type of drug
Item
Type of drug
text
C0457591 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Alcohol breath test
C0202306 (UMLS CUI-1)
Date of test
Item
Exact date of test
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of test
Item
Exact time of test
time
C0202306 (UMLS CUI [1,1])
C0429928 (UMLS CUI [1,2])
Item
Result of Alcohol breath test
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of Alcohol breath test
Code List
Result of Alcohol breath test
CL Item
Positive (P)
CL Item
Negative (N)
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