ID

25556

Description

Study part: Study Conclusion. 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. 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. Study ID: 101468/201. Clinical Study ID: 101468/201

Keywords

Versions (3)
  1. 9/5/17 9/5/17 -
  2. 5/10/19 5/10/19 -
  3. 5/10/19 5/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 5, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Study Conclusion Ropinirole Restless Legs Syndrome 101468/201

English

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
STUDY CONCLUSION
Description

STUDY CONCLUSION

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Did the subject complete the study as planned?
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
If ‘No’, mark one most appropriate category:
Description

reason

Data type

integer

Alias
UMLS CUI [1]
C0392360
Other, please specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Comments on reason for withdrawal:
Description

reason for withdrawal

Data type

text

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

Date of withdrawal

Data type

date

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

Time of withdrawal

Data type

time

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

Date of final dose

Data type

date

Alias
UMLS CUI [1]
C1531784
Time of final dose:
Description

Time of final dose

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0013227
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
STUDY CONCLUSION
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
study subject participation status
Item
Did the subject complete the study as planned?
boolean
C2348568 (UMLS CUI [1])
Item
If ‘No’, mark one most appropriate category:
integer
C0392360 (UMLS CUI [1])
reason
Code List
If ‘No’, 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
Item
Other, please specify
text
C0205394 (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])
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