ID

17013

Description

Study Sponsor: Astellas Study Title Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0002 Trial Registry Identification Number(#'s) NCT01416116 EudraCT Number: 2010-023258-34 Medical Condition Neuropathic pain Phase Phase 4 http://clinicaltrials.gov/show/NCT01416116 End of Study End of Study

Link

http://clinicaltrials.gov/show/NCT01416116

Keywords

  1. 8/21/16 8/21/16 -
Uploaded on

August 21, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

End of Study Form 5 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

End of Study Form 5 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

End of Study
Description

End of Study

Did subject complete the study?
Description

If 'NO', please provide details below.

Data type

integer

Alias
UMLS CUI [1]
C2348577
Withdrawal Date
Description

Withdrawal Date

Data type

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
Primary Reason for Withdrawal
Description

If 'Primary Reason for Withdrawal' is 'Adverse Event', please provide details on 'Adverse Event' form.

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
undefined item
Description

undefined item

Data type

integer

If 'Protocol Violation', specify
Description

Protocol Violation

Data type

text

Alias
UMLS CUI [1]
C1709750
If 'Other', specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394

Similar models

End of Study Form 5 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
End of Study
Item
Did subject complete the study?
integer
C2348577 (UMLS CUI [1])
Code List
Did subject complete the study?
CL Item
no (0)
CL Item
yes (1)
Withdrawal Date
Item
Withdrawal Date
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Reason for Withdrawal
Item
Primary Reason for Withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item
integer
Code List
undefined item
CL Item
Adverse event (1 )
CL Item
Withdrawal of consent (2 )
CL Item
Subject lost to follow up (3 )
CL Item
Protocol violation (4 )
CL Item
Pregnancy (5 )
CL Item
Other (6 )
Protocol Violation
Item
If 'Protocol Violation', specify
text
C1709750 (UMLS CUI [1])
Other
Item
If 'Other', specify
text
C0205394 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial