ID

16867

Beschreibung

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 2/5: Randomization Vital Signs: 75 mins prior to patch application Vital Signs: 15 mins prior to patch application Post patch application and post patch removal

Link

http://clinicaltrials.gov/show/NCT01416116

Stichworte

Versionen (2)
  1. 24.07.16 24.07.16 -
  2. 11.08.16 11.08.16 -
Hochgeladen am

11. August 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Treatment Visit Form 2/5 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

Englisch

Treatment Visit Form 2/5 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 Formulare  
Randomization
Beschreibung

Randomization

Date of Randomization
Beschreibung

Date of Randomization

Datentyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Randomization Number
Beschreibung

Randomization Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0034656
Dose/Group
Beschreibung

Dose/Group

Datentyp

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0441833
Vital Signs: 75 mins prior to patch application
Beschreibung

Vital Signs: 75 mins prior to patch application

Assessment Date
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Scheduled Time
Beschreibung

Scheduled Time

Datentyp

time

Alias
UMLS CUI [1]
C0086960
Assessment Time
Beschreibung

Assessment Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Position
Beschreibung

Position

Datentyp

integer

Alias
UMLS CUI [1]
C0733755
Systolic Blood Pressure
Beschreibung

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

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C0232117
Vital Signs: 15 mins prior to patch application
Beschreibung

Vital Signs: 15 mins prior to patch application

Assessment Date
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Scheduled Time
Beschreibung

Scheduled Time

Datentyp

time

Alias
UMLS CUI [1]
C0086960
Assessment Time
Beschreibung

Assessment Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Position
Beschreibung

Position

Datentyp

integer

Alias
UMLS CUI [1]
C0733755
Systolic Blood Pressure
Beschreibung

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

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C0232117
Vital Signs: Post patch application and post patch rGeemnoevraatl
Beschreibung

Vital Signs: Post patch application and post patch rGeemnoevraatl

Assessment Date
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Scheduled Time
Beschreibung

Scheduled Time

Datentyp

time

Alias
UMLS CUI [1]
C0086960
Assessment Time
Beschreibung

Assessment Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Position
Beschreibung

Position

Datentyp

integer

Alias
UMLS CUI [1]
C0733755
Systolic Blood Pressure
Beschreibung

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

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C0232117
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Ähnliche Modelle

Treatment Visit Form 2/5 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 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Randomization
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Randomization Number
Item
Randomization Number
integer
C0030705 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Item
Dose/Group
integer
C3174092 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
Dose/Group
Code List
Dose/Group
CL Item
Arm 1: Lidocaine 4% (1)
CL Item
Arm 2: Tramadol (2)
Item Group
Vital Signs: 75 mins prior to patch application
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
time
C0086960 (UMLS CUI [1])
Assessment Time
Item
Assessment Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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
Vital Signs: 15 mins prior to patch application
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
time
C0086960 (UMLS CUI [1])
Assessment Time
Item
Assessment Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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
Vital Signs: Post patch application and post patch rGeemnoevraatl
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
time
C0086960 (UMLS CUI [1])
Assessment Time
Item
Assessment Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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])
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