ID

16871

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 End of Study Form 1/: Vital Signs Identification of Painful Area: Change NPRS 'average pain' score NPRS 'pain now' score Adverse Event 1 Concomitant Medication 1 Any Non-medication Therapy

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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End of Study Form 1/ 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

End of Study Form 1/ 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  
Vital Signs: 75 mins prior to patch application
Description

Vital Signs: 75 mins prior to patch application

Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Position
Description

Position

Data type

integer

Alias
UMLS CUI [1]
C0733755
Systolic Blood Pressure
Description

For any AE, please provide details on the 'Adverse Event' form.

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Description

Record any clinically significant abnormal findings/conditions identified during the exam on the Current Medical and Surgical History and/or Adverse Event form.

Data type

integer

Alias
UMLS CUI [1]
C0232117
Identification of Painful Area: Change
Description

Identification of Painful Area: Change

Is there any change in most painful area?
Description

If ‘Yes’, please provide details on 'Identification of Painful Area'

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0392747
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: 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
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
Tolerability score
Description

120 mins post patch removal

Data type

integer

Alias
UMLS CUI [1]
C3274448
Additional Information
Description

Additional Information

Was any adverse event reported or observed?
Description

If 'Yes', please provide details on 'Adverse Event' form.

Data type

integer

Alias
UMLS CUI [1]
C0877248
Is there any previous medication and /or concomitant medication to record?
Description

Concomitant medication

Data type

integer

Alias
UMLS CUI [1]
C2347852
Is there any non-medication therapy and/or changes in non-medication therapy to record?
Description

If 'Yes', please provide details on 'Non-medication Therapy' form.

Data type

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1518422
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Similar models

End of Study Form 1/ 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
Vital Signs: 75 mins prior to patch application
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Item
Position
integer
C0733755 (UMLS CUI [1])
Position
Code List
Position
CL Item
Supine (1 )
CL Item
Sitting (2 )
CL Item
Standing (3 )
Systolic Blood Pressure
Item
Systolic Blood Pressure
text
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
text
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse Rate
integer
C0232117 (UMLS CUI [1])
Item Group
Identification of Painful Area: Change
Item
Is there any change in most painful area?
integer
C0030193 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Pain Change
Code List
Is there any change in most painful area?
CL Item
no (0)
CL Item
yes (1)
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: Post patch application and post patch removal
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)
Item Group
Tolerability score: Post patch removal
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
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
Additional Information
Item
Was any adverse event reported or observed?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Was any adverse event reported or observed?
CL Item
no (0)
CL Item
yes (1)
Item
Is there any previous medication and /or concomitant medication to record?
integer
C2347852 (UMLS CUI [1])
Concomitant medication
Code List
Is there any previous medication and /or concomitant medication to record?
CL Item
no (0)
CL Item
yes (1)
Item
Is there any non-medication therapy and/or changes in non-medication therapy to record?
integer
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
non-medication therapy
Code List
Is there any non-medication therapy and/or changes in non-medication therapy to record?
CL Item
no (0)
CL Item
yes (1)
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