ID

27536

Description

Study Part: Study Conclusion Follow- Up (Visit 10). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Keywords

Versions (1)
  1. 11/19/17 11/19/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 19, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Study Conclusion Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165

English

Study Conclusion Follow- Up (Visit 10)

1 forms  
STUDY CONCLUSION
Description

STUDY CONCLUSION

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

Subject Number

Data type

text

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

Study Conclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
If ’NO’, mark the one most appropriate category
Description

Study Conclusion

Data type

integer

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
Other, Please specify
Description

Other

Data type

text

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

Comment reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0008976
Date of Withdrawal:
Description

Date of Withdrawal

Data type

date

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

Time of Withdrawal

Data type

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
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]
C0946444
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Similar models

Study Conclusion Follow- Up (Visit 10)

1 forms
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
text
C2348585 (UMLS CUI [1])
Study Conclusion
Item
Did the subject complete the study as planned?
boolean
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Item
If ’NO’, mark the one most appropriate category
integer
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Study Conclusion
Code List
If ’NO’, mark the one most appropriate category
CL Item
Adverse Event (complete Adverse Event Form) (1)
C0877248 (UMLS CUI-1)
(Comment:en)
CL Item
Insufficient therapeutic effect (2)
C1527144 (UMLS CUI-1)
(Comment:en)
CL Item
Deviation from Protocol (including non-compliance) (3)
C1321605 (UMLS CUI-1)
(Comment:en)
CL Item
Lost to Follow-Up (4)
C1302313 (UMLS CUI-1)
(Comment:en)
CL Item
Other (5)
C0205394 (UMLS CUI-1)
(Comment:en)
Other
Item
Other, Please specify
text
C0205394 (UMLS CUI [1])
Comment reason for withdrawal
Item
Comments on reason for withdrawal:
text
C0947611 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Date of Withdrawal
Item
Date of Withdrawal:
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Withdrawal
Item
Time of Withdrawal:
time
C2349954 (UMLS CUI [1,1])
C0040223 (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
C0946444 (UMLS CUI [1])
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