ID

16543

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 Screening Visit: Pregnancy Test Identification of Painful Area NPRS 'average pain' score NPRS 'pain now' score

Link

http://clinicaltrials.gov/show/NCT01416116

Keywords

Versions (1)
  1. 7/23/16 7/23/16 -
Uploaded on

July 23, 2016

DOI

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License

Creative Commons BY 4.0
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Screening Visit Form 4/4 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

Screening Visit Form 4/4 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
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
NPRS 'average pain' score
Description

NPRS 'average pain' score

Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
NPRS 'average' pain score
Description

NPRS 'average' pain score

Data type

integer

Alias
UMLS CUI [1]
C0582148
NPRS 'pain now' score
Description

NPRS 'pain now' score

Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
NPRS 'pain now' score
Description

NPRS 'pain now' score

Data type

integer

Alias
UMLS CUI [1]
C0582148
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Similar models

Screening Visit Form 4/4 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
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
NPRS 'average pain' score
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
NPRS 'average' pain score
integer
C0582148 (UMLS CUI [1])
NPRS 'average' pain score
Code List
NPRS 'average' pain score
CL Item
0 (0 )
CL Item
1 (1 )
CL Item
2 (2 )
CL Item
3 (3 )
CL Item
4 (4 )
CL Item
5 (5 )
CL Item
6 (6 )
CL Item
7 (7 )
CL Item
8 (8 )
CL Item
9 (9 )
CL Item
10 (10 )
Item Group
NPRS 'pain now' score
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
NPRS 'pain now' score
integer
C0582148 (UMLS CUI [1])
NPRS 'pain now' score
Code List
NPRS 'pain now' score
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
0 (0)
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