ID

36397

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 document contains the study conclusion form. In this Pregnancy information and Investigators’s Statement are included. The document has to be filled in for the end of study.

Nyckelord

Versioner (3)
  1. 2017-09-05 2017-09-05 -
  2. 2019-05-10 2019-05-10 -
  3. 2019-05-10 2019-05-10 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 maj 2019

DOI

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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

Engelsk

Study Conclusion (Pregnancy information, Investigators’s Statement)

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
STUDY CONCLUSION
Beskrivning

STUDY CONCLUSION

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the subject complete the study as planned?
Beskrivning

study subject participation status

Datatyp

text

Alias
UMLS CUI [1]
C2348568
If subject did not complete the study as planned, mark one most appropriate category
Beskrivning

Reason, no completion as planned

Datatyp

integer

Alias
UMLS CUI [1]
C1709849
If other reason, please specify
Beskrivning

Other reason

Datatyp

text

Alias
UMLS CUI [1]
C3840932
Comments on reason for withdrawal
Beskrivning

reason for withdrawal

Datatyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Date of withdrawal
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2349954
Time of withdrawal
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2349954
Date of final dose
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1531784
Time of final dose
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0013227
Pregnancy Information
Beskrivning

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did subject become pregnant during the study?
Beskrivning

Pregnancy during study

Datatyp

text

Alias
UMLS CUI [1]
C0549206
Did the female partner of a male subject become pregnant during the study?
Beskrivning

Pregnant Partner in relationship

Datatyp

text

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0682323
Statement investigator
Beskrivning

Statement investigator

Alias
UMLS CUI-1
C1710187
UMLS CUI-2
C2826892
Check all Adverse Event forms are up to date and complete
Beskrivning

Tick when done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1283174
Check that the Concomitant Medication form is up to date
Beskrivning

Tick when done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1283174
Check that all appropriate pages are signed (thus indicating completion) and dated
Beskrivning

Tick when done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C1283174
Check that laboratory results are included
Beskrivning

Tick when done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1283174
Investigator signature
Beskrivning

I certify to the best of my knowledge, that the observations and findings are recorded correctly and completely in this CRF.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study Conclusion (Pregnancy information, Investigators’s Statement)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
STUDY CONCLUSION
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Did the subject complete the study as planned?
text
C2348568 (UMLS CUI [1])
study subject participation status
Code List
Did the subject complete the study as planned?
CL Item
Yes (Y)
CL Item
No (N)
Item
If subject did not complete the study as planned, mark one most appropriate category
integer
C1709849 (UMLS CUI [1])
reason
Code List
If subject did not complete the study as planned, mark one most appropriate category
CL Item
Adverse event (complete adverse event form)  (1)
CL Item
Insufficient therapeutic effect  (2)
CL Item
Deviation from protocol (including non-compliance)  (3)
CL Item
Lost to Follow-Up  (4)
CL Item
Other (5)
Other reason
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1])
reason for withdrawal
Item
Comments on reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Date of withdrawal
Item
Date of withdrawal
date
C0011008 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Time of withdrawal
Item
Time of withdrawal
time
C0040223 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Date of final dose
Item
Date of final dose
date
C1531784 (UMLS CUI [1])
Time of final dose
Item
Time of final dose
time
C1522314 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did subject become pregnant during the study?
text
C0549206 (UMLS CUI [1])
Pregnancy during study
Code List
Did subject become pregnant during the study?
CL Item
Not applicable (Not of child bearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the female partner of a male subject become pregnant during the study?
text
C0549206 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
Pregnant Partner in relationship
Code List
Did the female partner of a male subject become pregnant during the study?
CL Item
Not applicable (Subject is female, female partner not of childbearing potential or female partner) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Statement investigator
C1710187 (UMLS CUI-1)
C2826892 (UMLS CUI-2)
Adverse Event
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Concomitant Medication
Item
Check that the Concomitant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Completion
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
boolean
C0805732 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Laboratory results
Item
Check that laboratory results are included
boolean
C1254595 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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