ID

16863

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: NPRS 'pain now' score: 75 mins prior to patch NPRS 'pain now' score: 40, 15 mins prior to patch NPRS 'pain now' score: Post patch application and post patch removal Tolerability score: Post patch removal NPRS 'average pain' score: Day 1-3 NPRS 'pain now' score: Day 1-3

Link

http://clinicaltrials.gov/show/NCT01416116

Keywords

Versions (1)
  1. 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 5/5 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 5/5 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  
NPRS 'pain now' score: 75 mins prior to patch
Description

NPRS 'pain now' score: 75 mins prior to patch

Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Scheduled Time
Description

75 mins prior to patch application

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Assessment Time
Description

Assessment Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1516048
NPRS 'pain now' score
Description

NPRS 'pain now' score

Data type

integer

Alias
UMLS CUI [1]
C0582148
NPRS 'pain now' score: 40, 15 mins prior to patch
Description

NPRS 'pain now' score: 40, 15 mins prior to patch

Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Scheduled Time
Description

Scheduled Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Assessment Time
Description

Assessment Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1516048
NPRS 'pain now' score
Description

NPRS 'pain now' score

Data type

integer

Alias
UMLS CUI [1]
C0582148
NPRS 'pain now' score: Post patch application and post patch removal
Description

NPRS 'pain now' score: Post patch application and post patch removal

Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Scheduled Time
Description

75 mins prior to patch application

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Assessment Time
Description

Assessment Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1516048
NPRS 'pain now' score
Description

NPRS 'pain now' score

Data type

integer

Alias
UMLS CUI [1]
C0582148
Tolerability score: Post patch removal
Description

Tolerability score: Post patch removal

Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Scheduled Time
Description

75 mins prior to patch application

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Assessment Time
Description

Assessment Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1516048
Tolerability score
Description

120 mins post patch removal

Data type

integer

Alias
UMLS CUI [1]
C3274448
NPRS 'average pain' score: Day 1-3
Description

NPRS 'average pain' score: Day 1-3

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 [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Assessment Time
Description

Assessment Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1516048
NPRS 'average pain' score
Description

NPRS 'average pain' score

Data type

integer

Alias
UMLS CUI [1]
C0582148
Form: NPRS 'pain now' score: Day 1-3
Description

Form: NPRS 'pain now' score: Day 1-3

Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Scheduled Time
Description

75 mins prior to patch application

Data type

integer

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Assessment Time
Description

Assessment Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1516048
NPRS 'pain now' score
Description

NPRS 'pain now' score

Data type

integer

Alias
UMLS CUI [1]
C0582148
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Similar models

Treatment Visit Form 5/5 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
NPRS 'pain now' score: 75 mins prior to patch
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
time
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Assessment Time
Item
Assessment Time
time
C0040223 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
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)
Item Group
NPRS 'pain now' score: 40, 15 mins prior to patch
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
time
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Assessment Time
Item
Assessment Time
time
C0040223 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
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)
Item Group
NPRS 'pain now' score: Post patch application and post patch removal
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
time
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Assessment Time
Item
Assessment Time
time
C0040223 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
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)
Item Group
Tolerability score: Post patch removal
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
time
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Assessment Time
Item
Assessment Time
time
C0040223 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Item
Tolerability score
integer
C3274448 (UMLS CUI [1])
NPRS 'pain now' score
Code List
Tolerability 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)
Item Group
NPRS 'average pain' score: Day 1-3
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Scheduled Time
integer
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Scheduled Time
Code List
Scheduled Time
CL Item
Day 1 (Day of Patch Application) (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
Assessment Time
Item
Assessment Time
time
C0040223 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Item
NPRS 'average pain' score
integer
C0582148 (UMLS CUI [1])
NPRS 'pain now' score
Code List
NPRS 'average pain' 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)
Item Group
Form: NPRS 'pain now' score: Day 1-3
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Scheduled Time
integer
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Scheduled Time
Code List
Scheduled Time
CL Item
1: Day 1 (Day of Patch Application) (1)
CL Item
2: Day 2 (2)
CL Item
3: Day 3 (3)
Assessment Time
Item
Assessment Time
time
C0040223 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
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)
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