ID

16865

Beskrivning

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

Länk

http://clinicaltrials.gov/show/NCT01416116

Nyckelord

  1. 2016-07-25 2016-07-25 -
  2. 2016-08-11 2016-08-11 -
Uppladdad den

11 augusti 2016

DOI

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Licens

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
Beskrivning

Application of Lidocaine

Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Start Time
Beskrivning

Start Time

Datatyp

time

Alias
UMLS CUI [1]
C1301880
Stop Time
Beskrivning

Stop Time

Datatyp

time

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

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

Datatyp

integer

Alias
UMLS CUI [1]
C0366525
Administration of Tramadol
Beskrivning

Administration of Tramadol

Dosing Date
Beskrivning

Dosing Date

Datatyp

date

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

Dosing Time

Datatyp

time

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

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

Datatyp

integer

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

NPRS 'average pain' score prior to patch application

Date of Assessment
Beskrivning

Date of Assessment

Datatyp

date

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

NPRS 'average' pain score

Datatyp

integer

Alias
UMLS CUI [1]
C0582148
Application of Qutenza
Beskrivning

Application of Qutenza

Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Start Time
Beskrivning

Start Time

Datatyp

time

Alias
UMLS CUI [1]
C1301880
Stop Time
Beskrivning

Stop Time

Datatyp

time

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

Application of Qutenza: Treatment Area

Head and Neck
Beskrivning

Head and Neck

Datatyp

text

Alias
UMLS CUI [1]
C0460004
Arms
Beskrivning

Arms

Datatyp

text

Alias
UMLS CUI [1]
C1140618
Hands
Beskrivning

Hands

Datatyp

text

Alias
UMLS CUI [1]
C0018563
Torso
Beskrivning

Torso

Datatyp

text

Alias
UMLS CUI [1]
C0460005
Legs
Beskrivning

Legs

Datatyp

text

Alias
UMLS CUI [1]
C1140621
Feet
Beskrivning

Feet

Datatyp

text

Alias
UMLS CUI [1]
C0016504
Treatment Area Size
Beskrivning

Treatment Area Size

Datatyp

integer

Måttenheter
  • cm²
Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C0456389
cm²
Treatment Patch No
Beskrivning

Treatment Patch No

Datatyp

integer

Treatment patch %
Beskrivning

Treatment patch %

Datatyp

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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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