ID

36907

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 Pre-dose Drug screen, Pre-dose pregnancy test and the pre-dose alcohol test form. It has to be filled in at Day 1.

Keywords

Versions (2)
  1. 9/1/17 9/1/17 -
  2. 6/21/19 6/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 21, 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

English

Pre- Dose Drug Screening, Pregnancy test, Alcohol test

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Pre-dose Drug Screening (Urine)
Description

Pre-dose Drug Screening (Urine)

Alias
UMLS CUI-1
C0202274
Date of test
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2826247
Time of test
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0429928
Were there any contra-indicated drugs detected?
Description

If you tick ‘Yes’, please record all the relevant contra-indicated drugs below. If positive please withdraw the subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
If there are contraindicateddrugs, please specify 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
Pre-dose Alcohol test
Description

Pre-dose Alcohol test

Alias
UMLS CUI-1
C0202304
Date of test
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2826247
Time of test
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0429928
Alcohol test finding
Description

If positive please withdraw the subject from the study.

Data type

text

Alias
UMLS CUI [1]
C0495718
Pre-dose Pregnancy test
Description

Pre-dose Pregnancy test

Alias
UMLS CUI-1
C0032976
Was a pregnancy test carried out?
Description

Test performance

Data type

text

Alias
UMLS CUI [1,1]
C1518965
UMLS CUI [1,2]
C0032976
If test was not performed, please specify reason
Description

Test not performed, reason

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3841220
UMLS CUI [1,3]
C0032976
If test wasperformed, please specify Date of test
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2826247
If test wasperformed, please specify Time of test
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0429928
Test result
Description

If ‘Positive’, withdraw subject from the study

Data type

text

Alias
UMLS CUI [1]
C0427777
Test type
Description

Pregnancy test type

Data type

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0332307
If other test type, pease specify
Description

Other Pregnancy test type

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0332307
Laboratory name, if applicable
Description

Ensure result is included on laboratory report

Data type

text

Alias
UMLS CUI [1]
C3258037
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Similar models

Pre- Dose Drug Screening, Pregnancy test, Alcohol test

1 forms
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 Group
Pre-dose Drug Screening (Urine)
C0202274 (UMLS CUI-1)
Date of test
Item
Date of test
date
C2826247 (UMLS CUI [1])
Time of test
Item
Time of test
time
C0429928 (UMLS CUI [1])
Item
Were there any contra-indicated drugs detected?
text
C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Contraindication drugs
Code List
Were there any contra-indicated drugs detected?
CL Item
Yes (Y)
CL Item
No (N)
Type of Drug
Item
If there are contraindicateddrugs, please specify type of Drug
text
C0457591 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pre-dose Alcohol test
C0202304 (UMLS CUI-1)
Date of test
Item
Date of test
date
C2826247 (UMLS CUI [1])
Time of test
Item
Time of test
time
C0429928 (UMLS CUI [1])
Item
Alcohol test finding
text
C0495718 (UMLS CUI [1])
Alcohol test finding
Code List
Alcohol test finding
CL Item
Positive (P)
CL Item
Negative (N)
Item Group
Pre-dose Pregnancy test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test carried out?
text
C1518965 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Test performance
Code List
Was a pregnancy test carried out?
CL Item
Yes (Y)
CL Item
No (N)
Item
If test was not performed, please specify reason
text
C0566251 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
Test performance
Code List
If test was not performed, please specify reason
Date of test
Item
If test wasperformed, please specify Date of test
date
C2826247 (UMLS CUI [1])
Time of test
Item
If test wasperformed, please specify Time of test
time
C0429928 (UMLS CUI [1])
Item
Test result
text
C0427777 (UMLS CUI [1])
Test result
Code List
Test result
CL Item
Positive (P)
CL Item
Negative (N)
Item
Test type
integer
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Pregnancy test type
Code List
Test type
CL Item
Dipstick urine HCG (1)
CL Item
Serum HCG (2)
CL Item
Other (3)
Other Pregnancy test type
Item
If other test type, pease specify
text
C0205394 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Laboratory name
Item
Laboratory name, if applicable
text
C3258037 (UMLS CUI [1])
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