ID
36914
Beskrivning
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.
Nyckelord
Versioner (2)
- 2017-09-01 2017-09-01 -
- 2019-06-21 2019-06-21 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
21 juni 2019
DOI
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Licens
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
Laboratory Collections for Screening
- StudyEvent: ODM
Beskrivning
Clinical chemistry and haematology
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0018941
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
laboratory findings blood sampling
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0005834
Beskrivning
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
If ‘Yes’, please record diagnosis on Baseline Signs and Symptoms page.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0042014
Beskrivning
Drug Screening (Urine)
Alias
- UMLS CUI-1
- C0202274
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Beskrivning
If ‘Yes’, please withdraw subject and record all the relevant contra-indicated drugs below.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1301624
- UMLS CUI [1,2]
- C0013227
Beskrivning
Type of Drug
Datatyp
text
Alias
- UMLS CUI [1]
- C0457591
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
HIV and Hepatitis B and C
Alias
- UMLS CUI-1
- C0019682
- UMLS CUI-2
- C0019163
- UMLS CUI-3
- C0019196
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Beskrivning
If positive please withdraw the subject from the study.
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Beskrivning
Pregnancy test performance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1518965
Beskrivning
No test performance, reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0032976
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032976
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0032976
Beskrivning
Pregnancy test result
Datatyp
text
Alias
- UMLS CUI [1]
- C0427777
Beskrivning
Dipstick urine HCG
Datatyp
text
Alias
- UMLS CUI [1]
- C1254846
Beskrivning
Serum HCG
Datatyp
text
Alias
- UMLS CUI [1]
- C2348195
Beskrivning
Other pregnancy test types
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0032976
- UMLS CUI [1,3]
- C0332307
Beskrivning
Laboratory name
Datatyp
text
Alias
- UMLS CUI [1]
- C0022877
Beskrivning
Alcohol test
Alias
- UMLS CUI-1
- C0202304
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032976
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0032976
Beskrivning
Alcohol test finding
Datatyp
text
Alias
- UMLS CUI [1]
- C0495718
Similar models
Laboratory Collections for Screening
- StudyEvent: ODM
C0018941 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0019163 (UMLS CUI-2)
C0019196 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1518965 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])