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)
- 9/1/17 9/1/17 -
- 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
Pre- Dose Drug Screening, Pregnancy test, Alcohol test
- StudyEvent: ODM
Description
Pre-dose Drug Screening (Urine)
Alias
- UMLS CUI-1
- C0202274 (Urine drug screen)
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2826247 (Test Date)
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1]
- C0429928 (Test time)
- SNOMED
- 252127002
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 (Medical contraindication)
- SNOMED
- 397745006
- LOINC
- LA27164-5
- UMLS CUI [1,2]
- C0013227 (Pharmaceutical Preparations)
- SNOMED
- 763158003
- LOINC
- LP100609-9
Description
Type of Drug
Data type
text
Alias
- UMLS CUI [1]
- C0457591 (Type of drug)
- SNOMED
- 229753003
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611 (Comment)
- LOINC
- LP72293-1
Description
Pre-dose Alcohol test
Alias
- UMLS CUI-1
- C0202304 (Ethanol measurement)
- SNOMED
- 430837008
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2826247 (Test Date)
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1]
- C0429928 (Test time)
- SNOMED
- 252127002
Description
If positive please withdraw the subject from the study.
Data type
text
Alias
- UMLS CUI [1]
- C0495718 (Finding of alcohol in blood)
- SNOMED
- 274776000
Description
Pre-dose Pregnancy test
Alias
- UMLS CUI-1
- C0032976 (Pregnancy Tests)
- SNOMED
- 74036000
Description
Test performance
Data type
text
Alias
- UMLS CUI [1,1]
- C1518965 (Performance Status)
- UMLS CUI [1,2]
- C0032976 (Pregnancy Tests)
- SNOMED
- 74036000
Description
Test not performed, reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0566251 (Reason and justification)
- SNOMED
- 288830005
- UMLS CUI [1,2]
- C3841220 (Test not performed)
- LOINC
- LA13546-9
- UMLS CUI [1,3]
- C0032976 (Pregnancy Tests)
- SNOMED
- 74036000
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2826247 (Test Date)
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1]
- C0429928 (Test time)
- SNOMED
- 252127002
Description
If ‘Positive’, withdraw subject from the study
Data type
text
Alias
- UMLS CUI [1]
- C0427777 (Pregnancy test finding)
- SNOMED
- 250421003
Description
Pregnancy test type
Data type
integer
Alias
- UMLS CUI [1,1]
- C0032976 (Pregnancy Tests)
- SNOMED
- 74036000
- UMLS CUI [1,2]
- C0332307 (Type - attribute)
- SNOMED
- 261664005
Description
Other Pregnancy test type
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394 (Other)
- SNOMED
- 74964007
- LOINC
- LP21049-9
- UMLS CUI [1,2]
- C0032976 (Pregnancy Tests)
- SNOMED
- 74036000
- UMLS CUI [1,3]
- C0332307 (Type - attribute)
- SNOMED
- 261664005
Description
Ensure result is included on laboratory report
Data type
text
Alias
- UMLS CUI [1]
- C3258037 (Performing laboratory name)
- LOINC
- LP135668-4
Similar models
Pre- Dose Drug Screening, Pregnancy test, Alcohol test
- StudyEvent: ODM
C0013227 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
C0032976 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
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