ID

16786

Description

QUTENZA™ versus Pregabalin in Subjects with Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study Medicine or Vaccine (generic name) capsaicin Last Visit in Week 8 End of Study Sponsor Identification Number QTZ-EC-0004 Trial Registry Identification Number(#'s) NCT01713426 EudraCT Number: 2011-005872-41

Keywords

Versions (1)
  1. 8/7/16 8/7/16 -
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August 7, 2016

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Creative Commons BY-NC-ND 3.0
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Last Visit and End of Study QTZ-EC-0004 ELEVATE NCT01713426

English

Last Visit and End of Study QTZ-EC-0004 ELEVATE NCT01713426

1 forms  
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.)
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
If Yes, please provide the Date of Visit.
Description

Date of visit

Data type

date

Measurement units
  • dd/MMM/yyyy
dd/MMM/yyyy
Biochemistry
Description

Biochemistry

Alias
UMLS CUI-1
C0005477
Form Not Done
Description

Biochemistry

Data type

text

Alias
UMLS CUI [1]
C0005477
Were samples taken?
Description

Samples Taken

Data type

boolean

Alias
UMLS CUI [1]
C1277698
Date of Sample Taken
Description

Date of Samples Taken

Data type

date

Measurement units
  • dd/MMM/yyyy
Alias
UMLS CUI [1]
C0460065
dd/MMM/yyyy
Laboratory Interpretation (If LAB interpretetation is abnormal, please select assessment items below and report the interpretation for each.)
Description

Laboratory Interpretation

Data type

text

Alias
UMLS CUI [1]
C0262707
Laboratory Tests
Description

Biochemistry test

Data type

text

Alias
UMLS CUI [1]
C1655775
Laboratory Interpretation: Specification
Description

Laboratory Interpretation: Specification

Data type

text

Alias
UMLS CUI [1,1]
C0262707
UMLS CUI [1,2]
C2348235
Record any clinically significant abnormal findings/conditions identified during the exam on Medical and Surgical History and/or Adverse Event form.
Description

Biochemistry: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0947611
Dynamic Mechanical Allodynia
Description

Dynamic Mechanical Allodynia

Alias
UMLS CUI-1
C2936719
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
Description

Dynamic Mechanical Allodynia

Data type

text

Alias
UMLS CUI [1]
C2936719
Intensity of dynamic mechanical allodynia (0=No Pain; 10=Pain as bad as patient can imagine)
Description

Dynamic Mechanical Allodynia: Intensity

Data type

integer

Alias
UMLS CUI [1]
C0522510
Total surface area size of area of dynamic mechanical allodynia
Description

Dynamic Mechanical Allodynia: Size

Data type

float

Measurement units
  • cm^2
Alias
UMLS CUI [1,1]
C0522510
UMLS CUI [1,2]
C0456389
cm^2
Healthcare Resource Use
Description

Healthcare Resource Use

Alias
UMLS CUI-1
C1704738
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
Description

Healthcare Resource Use

Data type

text

Alias
UMLS CUI [1]
C1704738
Number of contacts with a healthcare professional related to neuropathic pain, since the last visit
Description

Number of contacts for Neuropathic Pains

Data type

float

Alias
UMLS CUI [1,1]
C1444281
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C3714625
Number of contacts with a healthcare professional for other causes, since the last visit
Description

Number of contacts: Specification

Data type

float

Alias
UMLS CUI [1,1]
C1444281
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C2348235
Tolerability Assessment
Description

Tolerability Assessment

Alias
UMLS CUI-1
C3274448
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
Description

Tolerability Assessment

Data type

text

Alias
UMLS CUI [1]
C3274448
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
Description

Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
End of Study
Description

End of Study

Alias
UMLS CUI-1
C0444496
Date of Last Evaluation
Description

Date of Last Evaluation

Data type

date

Measurement units
  • dd/MMM/yyyy
Alias
UMLS CUI [1]
C0805839
dd/MMM/yyyy
Primary End of Treatment/Study Reason (Primary End of Treatment/Study Reason: For any randomized/registered subject that did not receive any study drug please select RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG.) (If primary "End of Treatment/Study Reason" is "Adverse Event" or "Death", please provide details on "Adverse Events" form.)
Description

End of Study: Reason

Data type

text

Alias
UMLS CUI [1]
C0444496
Date of Withdrawal
Description

Date of Withdrawal

Data type

date

Measurement units
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
dd/MMM/yyyy
If "Protocol Viiolation", specify:
Description

Protocol Violation

Data type

text

Alias
UMLS CUI [1]
C1709750
If primary reason is "Other", specify:
Description

End of Study: Reason Specification

Data type

text

Alias
UMLS CUI [1,1]
C0444496
UMLS CUI [1,2]
C2348235
Ask the patient: Are you willing to continue treatment with the study medication
Description

Continuation status

Data type

boolean

Alias
UMLS CUI [1]
C0805733
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Similar models

Last Visit and End of Study QTZ-EC-0004 ELEVATE NCT01713426

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Item
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.)
text
C0545082 (UMLS CUI [1])
Visit
Code List
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Date of visit
Item
If Yes, please provide the Date of Visit.
date
Item Group
Biochemistry
C0005477 (UMLS CUI-1)
Item
Form Not Done
text
C0005477 (UMLS CUI [1])
Biochemistry
Code List
Form Not Done
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Samples Taken
Item
Were samples taken?
boolean
C1277698 (UMLS CUI [1])
Date of Samples Taken
Item
Date of Sample Taken
date
C0460065 (UMLS CUI [1])
Item
Laboratory Interpretation (If LAB interpretetation is abnormal, please select assessment items below and report the interpretation for each.)
text
C0262707 (UMLS CUI [1])
Laboratory Interpretation
Code List
Laboratory Interpretation (If LAB interpretetation is abnormal, please select assessment items below and report the interpretation for each.)
CL Item
Abnormal (Abnormal)
CL Item
Normal (Normal)
Item
Laboratory Tests
text
C1655775 (UMLS CUI [1])
Biochemistry test
Code List
Laboratory Tests
CL Item
Alkaline Phosphatase (Alkaline Phosphatase)
CL Item
ALT (ALT)
CL Item
AST (AST)
CL Item
BUN (BUN)
CL Item
Creatinine (Creatinine)
CL Item
Potassium (Potassium)
CL Item
Sodium (Sodium)
CL Item
TBL (TBL)
Item
Laboratory Interpretation: Specification
text
C0262707 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Laboratory Interpretation: Specification
Code List
Laboratory Interpretation: Specification
CL Item
Abnormal-not clinically significant (Abnormal-not clinically significant)
CL Item
Abnormal-clinically significant (Abnormal-clinically significant)
Biochemistry: Comment
Item
Record any clinically significant abnormal findings/conditions identified during the exam on Medical and Surgical History and/or Adverse Event form.
text
C0005477 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Dynamic Mechanical Allodynia
C2936719 (UMLS CUI-1)
Item
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
text
C2936719 (UMLS CUI [1])
Dynamic Mechanical Allodynia
Code List
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
CL Item
Done  (Done )
CL Item
Not Done (Not Done)
Item
Intensity of dynamic mechanical allodynia (0=No Pain; 10=Pain as bad as patient can imagine)
integer
C0522510 (UMLS CUI [1])
Dynamic Mechanical Allodynia: Intensity
Code List
Intensity of dynamic mechanical allodynia (0=No Pain; 10=Pain as bad as patient can imagine)
CL Item
0 (1)
CL Item
9 (10)
CL Item
10 (11)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
5 (6)
CL Item
6 (7)
CL Item
7 (8)
CL Item
8 (9)
Dynamic Mechanical Allodynia: Size
Item
Total surface area size of area of dynamic mechanical allodynia
float
C0522510 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item Group
Healthcare Resource Use
C1704738 (UMLS CUI-1)
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
text
C1704738 (UMLS CUI [1])
Healthcare Resource Use
Code List
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Number of contacts for Neuropathic Pains
Item
Number of contacts with a healthcare professional related to neuropathic pain, since the last visit
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
Number of contacts: Specification
Item
Number of contacts with a healthcare professional for other causes, since the last visit
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Tolerability Assessment
C3274448 (UMLS CUI-1)
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
text
C3274448 (UMLS CUI [1])
Tolerability Assessment
Code List
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Adverse Event
Item
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
boolean
C0877248 (UMLS CUI [1])
Item Group
End of Study
C0444496 (UMLS CUI-1)
Date of Last Evaluation
Item
Date of Last Evaluation
date
C0805839 (UMLS CUI [1])
Item
Primary End of Treatment/Study Reason (Primary End of Treatment/Study Reason: For any randomized/registered subject that did not receive any study drug please select RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG.) (If primary "End of Treatment/Study Reason" is "Adverse Event" or "Death", please provide details on "Adverse Events" form.)
text
C0444496 (UMLS CUI [1])
End of Study: Reason
Code List
Primary End of Treatment/Study Reason (Primary End of Treatment/Study Reason: For any randomized/registered subject that did not receive any study drug please select RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG.) (If primary "End of Treatment/Study Reason" is "Adverse Event" or "Death", please provide details on "Adverse Events" form.)
CL Item
Completed (Completed)
CL Item
Randomized/Registered but never received/dispensed study drug (Randomized/Registered but never received/dispensed study drug)
CL Item
Adverse Event (Adverse Event)
CL Item
Death (Death)
CL Item
Lack of efficacy (Lack of efficacy)
CL Item
Lost to Follow-Up (Lost to Follow-Up)
CL Item
Progressive Disease (Progressive Disease)
CL Item
Protocol Violation (Protocol Violation)
CL Item
Withdrawal by Subject (Withdrawal by Subject)
CL Item
Study terminated by sponsor (Study terminated by sponsor)
CL Item
Other (Other)
Date of Withdrawal
Item
Date of Withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Protocol Violation
Item
If "Protocol Viiolation", specify:
text
C1709750 (UMLS CUI [1])
End of Study: Reason Specification
Item
If primary reason is "Other", specify:
text
C0444496 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Continuation status
Item
Ask the patient: Are you willing to continue treatment with the study medication
boolean
C0805733 (UMLS CUI [1])
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