ID

16517

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 Screening Visit: Date of Visit Screening Status Informed Consent 1 Demographics Medical and Surgical History

Link

http://clinicaltrials.gov/show/NCT01416116

Keywords

Versions (2)
  1. 7/21/16 7/21/16 -
  2. 7/23/16 7/23/16 -
Uploaded on

July 21, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Screening Visit 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

Screening Visit 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  
Date of Visit
Description

Date of Visit

Date of Visit
Description

Field name: VDDT

Data type

date

Screening Status
Description

Screening Status

Is the subject a screen failure (signed an informed consent but was not randomized)?
Description

Field Name: DSYN

Data type

integer

Alias
UMLS CUI [1]
C1710476
Reason for Not Meeting Admission Criteria
Description

Field Name: SFDECOD

Data type

integer

Alias
UMLS CUI [1,1]
C0030673
UMLS CUI [1,2]
C0392360
If 'Other' specify
Description

Field Name: SFOTHSP

Data type

text

Alias
UMLS CUI [1]
C0205394
Informed Consent 1
Description

Informed Consent 1

Date of Informed Consent
Description

DSSTDT

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Birth Date
Description

Field Name: BRTHDT

Data type

date

Alias
UMLS CUI [1]
C0421451
Age
Description

Field Name: Age

Data type

integer

Measurement units
  • Years
Alias
UMLS CUI [1]
C0001779
Years
Race
Description

Field Name :RACE

Data type

integer

Alias
UMLS CUI [1]
C0034510
If 'Other', specify
Description

Field Name: RACEOTH

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0034510
Medical and Surgical History
Description

Medical and Surgical History

Is there any past or present Medical Condition? If 'Yes', please provide details below
Description

Field Name: MHANY

Data type

integer

Alias
UMLS CUI [1]
C0012634
MedicalCondition, specify
Description

Field Name: MHTERM

Data type

text

Alias
UMLS CUI [1]
C0012634
Onset Date
Description

Field Name: MHSTDT

Data type

date

Alias
UMLS CUI [1]
C0574845
Is Medical Condition ongoing? If 'No', please provide 'Recovered Date'.
Description

Field Name: MHONGO

Data type

integer

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0012634
Recovered Date
Description

Field Name: MHENDT

Data type

date

Alias
UMLS CUI [1,1]
C0237820
UMLS CUI [1,2]
C0011008
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Similar models

Screening Visit 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
Date of Visit
Date of Visit
Item
Date of Visit
date
Item Group
Screening Status
Item
Is the subject a screen failure (signed an informed consent but was not randomized)?
integer
C1710476 (UMLS CUI [1])
Screen failure
Code List
Is the subject a screen failure (signed an informed consent but was not randomized)?
CL Item
No (0)
CL Item
Yes (1)
Item
Reason for Not Meeting Admission Criteria
integer
C0030673 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
no admission, reason
Code List
Reason for Not Meeting Admission Criteria
CL Item
Not fulfill inclusion or exclusion criteria (1 )
CL Item
Untoward Medical Symptoms (3 )
CL Item
Subject lost to follow up (7 )
CL Item
Other (99 )
CL Item
Withdrawal of consent (6 )
Other
Item
If 'Other' specify
text
C0205394 (UMLS CUI [1])
Item Group
Informed Consent 1
Date of Informed Consent
Item
Date of Informed Consent
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Birth Date
Item
Birth Date
date
C0421451 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (1 )
CL Item
Black or African American (3 )
CL Item
Asian (4 )
CL Item
American Indian or Alaskan Native (5 )
CL Item
Native Hawaiian or Other Pacific Islander (6 )
CL Item
Other (99 )
Other race
Item
If 'Other', specify
text
C0205394 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Item Group
Medical and Surgical History
Item
Is there any past or present Medical Condition? If 'Yes', please provide details below
integer
C0012634 (UMLS CUI [1])
medical condition
Code List
Is there any past or present Medical Condition? If 'Yes', please provide details below
CL Item
No (0 )
CL Item
Yes (1 )
Medical Condition
Item
MedicalCondition, specify
text
C0012634 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C0574845 (UMLS CUI [1])
Item
Is Medical Condition ongoing? If 'No', please provide 'Recovered Date'.
integer
C0549178 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
ongoing
Code List
Is Medical Condition ongoing? If 'No', please provide 'Recovered Date'.
CL Item
No (0 )
CL Item
Yes (1 )
date of recovery
Item
Recovered Date
date
C0237820 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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