ID

36914

Beschreibung

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 documen contains the Laboratory Collections for Screening form.

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  1. 01.09.17 01.09.17 -
  2. 21.06.19 21.06.19 -
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GlaxoSmithKline

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21. Juni 2019

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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Englisch

Laboratory Collections for Screening

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Beschreibung

identification number

Datentyp

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Clinical chemistry and haematology
Beschreibung

Clinical chemistry and haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Date of blood sampling
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of blood sampling
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Comments:
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beschreibung

laboratory findings blood sampling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0005834
Urinalysis
Beschreibung

Urinalysis

Alias
UMLS CUI-1
C0042014
Date of urine sampling
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of urine sampling
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Comments:
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beschreibung

If ‘Yes’, please record diagnosis on Baseline Signs and Symptoms page.

Datentyp

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0042014
Drug Screening (Urine)
Beschreibung

Drug Screening (Urine)

Alias
UMLS CUI-1
C0202274
Date of urine sampling
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of urine sampling
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Were there any contra-indicated drugs detected?
Beschreibung

If ‘Yes’, please withdraw subject and record all the relevant contra-indicated drugs below.

Datentyp

text

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
Type of Drug
Beschreibung

Type of Drug

Datentyp

text

Alias
UMLS CUI [1]
C0457591
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
HIV and Hepatitis B and C
Beschreibung

HIV and Hepatitis B and C

Alias
UMLS CUI-1
C0019682
UMLS CUI-2
C0019163
UMLS CUI-3
C0019196
Date of blood sampling
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of blood sampling
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Comments:
Beschreibung

If positive please withdraw the subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Pregnancy test
Beschreibung

Pregnancy test

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

Pregnancy test performance

Datentyp

text

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

No test performance, reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3841220
UMLS CUI [1,3]
C0032976
Date of sample
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032976
Time of sample
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0032976
Pregnancy test result
Beschreibung

Pregnancy test result

Datentyp

text

Alias
UMLS CUI [1]
C0427777
Dipstick urine HCG
Beschreibung

Dipstick urine HCG

Datentyp

text

Alias
UMLS CUI [1]
C1254846
Serum HCG
Beschreibung

Serum HCG

Datentyp

text

Alias
UMLS CUI [1]
C2348195
If other pregnancy test types, please specify
Beschreibung

Other pregnancy test types

Datentyp

text

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

Laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C0022877
Alcohol test
Beschreibung

Alcohol test

Alias
UMLS CUI-1
C0202304
Date of sample
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032976
Time of sample
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0032976
Alcohol test finding
Beschreibung

Alcohol test finding

Datentyp

text

Alias
UMLS CUI [1]
C0495718
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Ähnliche Modelle

Laboratory Collections for Screening

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
identification number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Clinical chemistry and haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of blood sampling
Item
Time of blood sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
laboratory findings blood sampling
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C0022877 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Date of urine sampling
Item
Date of urine sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of urine sampling
Item
Time of urine sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
text
C0022877 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
laboratory findings urinalysis
Code List
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Drug Screening (Urine)
C0202274 (UMLS CUI-1)
Date of urine sampling
Item
Date of urine sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of urine sampling
Item
Time of urine sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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
Type of Drug
text
C0457591 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
HIV and Hepatitis B and C
C0019682 (UMLS CUI-1)
C0019163 (UMLS CUI-2)
C0019196 (UMLS CUI-3)
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of blood sampling
Item
Time of blood sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
Pregnancy test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test carried out?
text
C0032976 (UMLS CUI [1,1])
C1518965 (UMLS CUI [1,2])
Pregnancy test performance
Code List
Was a pregnancy test carried out?
CL Item
Yes (Y)
CL Item
No (N)
No test performance, reason
Item
If tes was not performed, please specify reason
text
C0566251 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
Date of sample
Item
Date of sample
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
Pregnancy test result
text
C0427777 (UMLS CUI [1])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Dipstick urine HCG
text
C1254846 (UMLS CUI [1])
Pregnancy test result
Code List
Dipstick urine HCG
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Serum HCG
text
C2348195 (UMLS CUI [1])
Pregnancy test result
Code List
Serum HCG
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Other pregnancy test types
Item
If other pregnancy test types, please 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
C0022877 (UMLS CUI [1])
Item Group
Alcohol test
C0202304 (UMLS CUI-1)
Date of sample
Item
Date of sample
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
Alcohol test finding
text
C0495718 (UMLS CUI [1])
Pregnancy test result
Code List
Alcohol test finding
CL Item
Positive (Positive)
CL Item
Negative (Negative)
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