ID

36091

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 a Screening, 5 Sessions each with 2 days and a Follow-up. 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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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

English

Drug Screening and Alcohol Breath Test for screening

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject No.
Description

Subject No.:

Data type

text

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158 (Other Coding)
LOINC
LA4728-7
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303 (Date of visit)
SNOMED
406543005
Drug Screening
Description

Drug Screening

Alias
UMLS CUI-1
C0373483 (Drug screen (procedure))
Exact time of urine sampling
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0042014 (Urinalysis)
SNOMED
167217005
LOINC
LP32744-2
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Exact time of blood sampling
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
UMLS CUI [1,2]
C0005834 (Collection of blood specimen for laboratory procedure)
SNOMED
82078001
LOINC
LP125037-4
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 (Detection)
UMLS CUI [1,2]
C1444657 (Contraindicated)
SNOMED
410536001
LOINC
LA4216-3
UMLS CUI [1,3]
C1254351 (Pharmacologic Substance)
LOINC
LP172750-4
Type of drug
Description

Type of drug

Data type

text

Alias
UMLS CUI [1]
C0457591 (Type of drug)
SNOMED
229753003
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611 (Comment)
LOINC
LP72293-1
Alcohol breath test
Description

Alcohol breath test

Alias
UMLS CUI-1
C0202306 (Ethanol measurement, breath)
SNOMED
1820004
Exact time of test
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0202306 (Ethanol measurement, breath)
SNOMED
1820004
UMLS CUI [1,2]
C0429928 (Test time)
SNOMED
252127002
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 (Ethanol measurement, breath)
SNOMED
1820004
UMLS CUI [1,2]
C1274040 (Result)
SNOMED
394617004
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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 time
Item
Exact time of urine sampling
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blodd sampling time
Item
Exact time of blood sampling
time
C0040223 (UMLS CUI [1,1])
C0005834 (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)
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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