ID

16865

Descripción

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

Palabras clave

Versiones (2)
  1. 25/7/16 25/7/16 -
  2. 11/8/16 11/8/16 -
Subido en

11 de agosto de 2016

DOI

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Licencia

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

Inglés

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

1 formularios  
Application of Lidocaine
Descripción

Application of Lidocaine

Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Start Time
Descripción

Start Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1301880
Stop Time
Descripción

Stop Time

Tipo de datos

time

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C0366525
Administration of Tramadol
Descripción

Administration of Tramadol

Dosing Date
Descripción

Dosing Date

Tipo de datos

date

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

Dosing Time

Tipo de datos

time

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

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

Tipo de datos

integer

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

NPRS 'average pain' score prior to patch application

Date of Assessment
Descripción

Date of Assessment

Tipo de datos

date

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

NPRS 'average' pain score

Tipo de datos

integer

Alias
UMLS CUI [1]
C0582148
Application of Qutenza
Descripción

Application of Qutenza

Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Start Time
Descripción

Start Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1301880
Stop Time
Descripción

Stop Time

Tipo de datos

time

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

Application of Qutenza: Treatment Area

Head and Neck
Descripción

Head and Neck

Tipo de datos

text

Alias
UMLS CUI [1]
C0460004
Arms
Descripción

Arms

Tipo de datos

text

Alias
UMLS CUI [1]
C1140618
Hands
Descripción

Hands

Tipo de datos

text

Alias
UMLS CUI [1]
C0018563
Torso
Descripción

Torso

Tipo de datos

text

Alias
UMLS CUI [1]
C0460005
Legs
Descripción

Legs

Tipo de datos

text

Alias
UMLS CUI [1]
C1140621
Feet
Descripción

Feet

Tipo de datos

text

Alias
UMLS CUI [1]
C0016504
Treatment Area Size
Descripción

Treatment Area Size

Tipo de datos

integer

Unidades de medida
  • cm²
Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C0456389
cm²
Treatment Patch No
Descripción

Treatment Patch No

Tipo de datos

integer

Treatment patch %
Descripción

Treatment patch %

Tipo de datos

text

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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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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
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
Treatment Patch No
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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