ID

16865

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 4/5: Application of Lidocaine Administration of Tramadol NPRS 'average pain' score prior to patch application Application of Qutenza

Link

http://clinicaltrials.gov/show/NCT01416116

Keywords

  1. 7/25/16 7/25/16 -
  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 4/5 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

Treatment Visit Form 4/5 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

Application of Lidocaine
Description

Application of Lidocaine

Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Number of Tubes Used
Description

Application of Lidocaine to be applied 70 mins prior to patch application

Data type

integer

Alias
UMLS CUI [1]
C0366525
Administration of Tramadol
Description

Administration of Tramadol

Dosing Date
Description

Dosing Date

Data type

date

Alias
UMLS CUI [1,1]
C0040610
UMLS CUI [1,2]
C0011008
Dosing Time
Description

Dosing Time

Data type

time

Alias
UMLS CUI [1,1]
C0040610
UMLS CUI [1,2]
C0040223
# of Tablets Taken
Description

Administration of Tramadol to be applied 30 mins prior to patch application.

Data type

integer

Alias
UMLS CUI [1,1]
C0040610
UMLS CUI [1,2]
C3174092
NPRS 'average pain' score prior to patch application
Description

NPRS 'average pain' score prior to patch application

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
Application of Qutenza
Description

Application of Qutenza

Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Application of Qutenza: Treatment Area
Description

Application of Qutenza: Treatment Area

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
Treatment Area Size
Description

Treatment Area Size

Data type

integer

Measurement units
  • cm²
Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C0456389
cm²
Treatment Patch No
Description

Treatment Patch No

Data type

integer

Treatment patch %
Description

Treatment patch %

Data type

text

Similar models

Treatment Visit Form 4/5 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
Application of Lidocaine
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
lidocain dose
Item
Number of Tubes Used
integer
C0366525 (UMLS CUI [1])
Item Group
Administration of Tramadol
Dosing Date
Item
Dosing Date
date
C0040610 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Dosing Time
Item
Dosing Time
time
C0040610 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Tramadol dose
Item
# of Tablets Taken
integer
C0040610 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item Group
NPRS 'average pain' score prior to patch application
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
NPRS 'average' pain score
integer
C0582148 (UMLS CUI [1])
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
Application of Qutenza
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Item Group
Application of Qutenza: Treatment Area
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])
Treatment Area Size
Item
Treatment Area Size
integer
C0087111 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Item
Treatment Patch No
integer
Code List
Treatment Patch No
CL Item
Patch 1 (1 )
CL Item
Patch 2 (2 )
CL Item
Patch 3 (3 )
CL Item
Patch 4 (4 )
Treatment patch %
Item
Treatment patch %
text

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