ID

16866

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 Treatment Visit Form 3/5: Pregnancy Test Identification of Painful Area: Change Identification of Painful Area Dermal Assessment

Link

http://clinicaltrials.gov/show/NCT01416116

Keywords

Versions (2)
  1. 7/24/16 7/24/16 -
  2. 8/11/16 8/11/16 -
Uploaded on

August 11, 2016

DOI

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License

Creative Commons BY 4.0
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Treatment Visit Form 3/5 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

English

Treatment Visit Form 3/5 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

1 forms  
Pregnancy Test
Description

Pregnancy Test

Is subject female and of childbearing potential?
Description

If 'childbearing potential-NO', please provide reason of childbearing potential NO. If 'childbearing potential-YES', please provide details of pregnancy test below.

Data type

integer

Alias
UMLS CUI [1]
C3831118
Reason Childbearing potential - NO
Description

Childbearing potential Reason

Data type

integer

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C1549995
If 'Other', specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Select 'Not Done' if serum/urine sample was not taken.
Description

Pregnancy test done

Data type

boolean

Alias
UMLS CUI [1]
C0032976
Date of Sample Taken
Description

Date of Sample Taken

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Result serum/urine pregnancy test
Description

pregnancy test result

Data type

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Identification of Painful Area: Change
Description

Identification of Painful Area: Change

Is there any change in most painful area?
Description

change in most painful area

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C0392747
Identification of Painful Area
Description

Identification of Painful Area

Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Head and Neck
Description

Head and Neck

Data type

text

Alias
UMLS CUI [1]
C0460004
Arms
Description

Arms

Data type

text

Alias
UMLS CUI [1]
C1140618
Hands
Description

Hands

Data type

text

Alias
UMLS CUI [1]
C0018563
Torso
Description

Torso

Data type

text

Alias
UMLS CUI [1]
C0460005
Legs
Description

Legs

Data type

text

Alias
UMLS CUI [1]
C1140621
Feet
Description

Feet

Data type

text

Alias
UMLS CUI [1]
C0016504
Total Painful/Sensitive Area Size
Description

pain area size

Data type

float

Measurement units
  • cm²
Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C0456389
cm²
Dermal Assessment
Description

Dermal Assessment

Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Scheduled Time
Description

Scheduled Time

Data type

integer

Alias
UMLS CUI [1]
C0086960
Assessment Time
Description

Assessment Time

Data type

time

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0040223
Dermal Assessment Scale
Description

Dermal Assessment Scale

Data type

integer

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C1516048
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Similar models

Treatment Visit Form 3/5 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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pregnancy Test
Item
Is subject female and of childbearing potential?
integer
C3831118 (UMLS CUI [1])
childbearing potential
Code List
Is subject female and of childbearing potential?
CL Item
No (0 )
CL Item
Yes (1 )
Item
Reason Childbearing potential - NO
integer
C3831118 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Childbearing potential Reason
Code List
Reason Childbearing potential - NO
CL Item
Female (2 yrs post-menopausal or surgically sterile) (1 )
CL Item
Other (99 )
Other
Item
If 'Other', specify
text
C0205394 (UMLS CUI [1])
Pregnancy test done
Item
Select 'Not Done' if serum/urine sample was not taken.
boolean
C0032976 (UMLS CUI [1])
Date of Sample Taken
Item
Date of Sample Taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result serum/urine pregnancy test
integer
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
pregnancy test
Code List
Result serum/urine pregnancy test
CL Item
Negative (0 )
CL Item
Positive (1 )
Item Group
Identification of Painful Area: Change
Item
Is there any change in most painful area?
integer
C0030193 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
change in most painful area
Code List
Is there any change in most painful area?
CL Item
no (0)
CL Item
yes (1)
Item Group
Identification of Painful Area
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Head and Neck
Item
Head and Neck
text
C0460004 (UMLS CUI [1])
Arms
Item
Arms
text
C1140618 (UMLS CUI [1])
Hands
Item
Hands
text
C0018563 (UMLS CUI [1])
Torso
Item
Torso
text
C0460005 (UMLS CUI [1])
Legs
Item
Legs
text
C1140621 (UMLS CUI [1])
Feet
Item
Feet
text
C0016504 (UMLS CUI [1])
pain area size
Item
Total Painful/Sensitive Area Size
float
C0030193 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Item Group
Dermal Assessment
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Scheduled Time
integer
C0086960 (UMLS CUI [1])
Scheduled Time
Code List
Scheduled Time
CL Item
1: 80 to 90 mins prior to patch application (1)
CL Item
2: 5 minutes post patch removal (2)
CL Item
3: 55 minutes post patch removal (3)
Assessment Time
Item
Assessment Time
time
C1516048 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Dermal Assessment Scale
integer
C1123023 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Dermal Assessment Scale
Code List
Dermal Assessment Scale
CL Item
no evidence of irritation (0 )
CL Item
minimal erythema barely perceptive (1 )
CL Item
definite erythema, readily visible; minimal edema or minimal popular response (2 )
CL Item
erythema and papules (3 )
CL Item
definite edema (4 )
CL Item
erythema, edema, and papules (5 )
CL Item
vesicular eruption (6 )
CL Item
strong reaction spreading beyond test site (7 )
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