ID

36028

Beschrijving

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Pregnancy Information and Study Conclusion form. It has to be filled in for follow-up.

Trefwoorden

Versies (1)
  1. 09-04-19 09-04-19 -
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GlaxoSmithKline

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9 april 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Engels

Pregnancy Information, Study Conclusion

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschrijving

Subject No.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschrijving

Panel ID

Datatype

text

Alias
UMLS CUI [1]
C3846158
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Pregnancy Information
Beschrijving

Pregnancy Information

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

(mark one box below) If 'Yes' record details on Pregnancy Notification Form.

Datatype

text

Alias
UMLS CUI [1]
C3828490
Did the female partner of a male patient become pregnant during the study?
Beschrijving

(mark one box below) If 'Yes' record details on Pregnancy Notification Form.

Datatype

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008972
Study Conclusion
Beschrijving

Study Conclusion

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

Subject completed study

Datatype

text

Alias
UMLS CUI [1,1]
C2983670
UMLS CUI [1,2]
C2986196
If subject did not complete the study, please mark the one most appropriate category
Beschrijving

IF you tick AE, please complete AE form.

Datatype

integer

Alias
UMLS CUI [1]
C3827242
If other reason, please specify
Beschrijving

Other reason

Datatype

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
Comments on reason for withdrawal
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0566251
Date of Withdrawal
Beschrijving

day month year

Datatype

date

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

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Date of Final Dose
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1762893
Time of Final Dose
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0946444
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Similar models

Pregnancy Information, Study Conclusion

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Pregnant during study
Code List
Did the subject become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the female partner of a male patient become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
undefined item
Code List
Did the female partner of a male patient become pregnant during the study?
CL Item
Not applicable (subject is female, female partner not of childbearing potential or no female partner) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Did the subject complete the study as planned?
text
C2983670 (UMLS CUI [1,1])
C2986196 (UMLS CUI [1,2])
Subject completed study
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, please mark the one most appropriate category
integer
C3827242 (UMLS CUI [1])
undefined item
Code List
If subject did not complete the study, please mark the one most appropriate category
CL Item
Adverse experience  (1)
CL Item
Protocol deviation (including non-compliance) (2)
CL Item
Lost to follow-up (3)
CL Item
Other (4)
Other reason
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Comments
Item
Comments on reason for withdrawal
text
C0947611 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
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
C1762893 (UMLS CUI [1])
Time of Final Dose
Item
Time of Final Dose
time
C0946444 (UMLS CUI [1])
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