ID
16700
Beschreibung
QUTENZA™ versus Pregabalin in Subjects with Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0004 Trial Registry Identification Number(#'s) NCT01713426 EudraCT Number: 2011-005872-41
Stichworte
Versionen (1)
- 01.08.16 01.08.16 -
Hochgeladen am
1. August 2016
DOI
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Lizenz
Creative Commons BY-NC-ND 3.0
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Baseline Visit QTZ-EC-0004 ELEVATE NCT01713426
Baseline Visit QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Eligibility: Inclusion
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013893
- UMLS CUI [1,2]
- C1512693
Beschreibung
Inclusion Criteria
Datentyp
text
Alias
- UMLS CUI [1]
- C1512693
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Physical Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Assessment Date
Datentyp
date
Maßeinheiten
- dd/MMM/yyyy
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Physical Examination: Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0947611
Beschreibung
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Vital signs
Datentyp
text
Alias
- UMLS CUI [1]
- C0518766
Beschreibung
Scheduled Time
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0086960
Beschreibung
Vital signs: Assessment Date
Datentyp
date
Maßeinheiten
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C2985720
Beschreibung
Vital signs: Assessment Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Beschreibung
Position
Datentyp
text
Beschreibung
Systolic Blood Pressure
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic Blood Pressure
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Pulse
Datentyp
float
Maßeinheiten
- Beats/Min
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
Vitals signs: Comment
Datentyp
text
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0947611
Beschreibung
Height and Weight
Alias
- UMLS CUI-1
- C0005890
- UMLS CUI-2
- C0005910
Beschreibung
Height and Weight
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
Beschreibung
Height and Weight: Assessment Date
Datentyp
date
Maßeinheiten
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C2985720
- UMLS CUI [2,1]
- C0005910
- UMLS CUI [2,2]
- C2985720
Beschreibung
Height
Datentyp
float
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
BMI
Datentyp
text
Maßeinheiten
- kg/m^2
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beschreibung
Pregnancy Test
Datentyp
text
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
Pregnancy Test: Reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0392360
Beschreibung
Pregnancy Test: Reason Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C2348235
Beschreibung
Pregnancy Test: Date
Datentyp
date
Maßeinheiten
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschreibung
Pregnancy Test: Result
Datentyp
text
Alias
- UMLS CUI [1]
- C0427777
Beschreibung
Randomization
Alias
- UMLS CUI-1
- C0034656
Beschreibung
Date of Randomization
Datentyp
date
Maßeinheiten
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Beschreibung
Treatment Group
Datentyp
text
Alias
- UMLS CUI [1]
- C1522541
Beschreibung
Date of First Study Drug Taken
Datentyp
date
Maßeinheiten
- dd/MMM/yyyy
Alias
- UMLS CUI [1]
- C3899436
Beschreibung
Painful Area: Change
Alias
- UMLS CUI-1
- C2032736
- UMLS CUI-2
- C0392747
Beschreibung
Painful Area
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2032736
- UMLS CUI [1,2]
- C0392747
Beschreibung
Painful Area: Change since Screening visit
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2032736
- UMLS CUI [1,2]
- C0392747
- UMLS CUI [1,3]
- C1409616
Beschreibung
Painful Area: Change Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2032736
- UMLS CUI [1,2]
- C0392747
- UMLS CUI [1,3]
- C2348235
Beschreibung
Painful Area
Alias
- UMLS CUI-1
- C2032736
Beschreibung
Painful Area
Datentyp
text
Alias
- UMLS CUI [1]
- C2032736
Beschreibung
Painful Area: Assessment Date
Datentyp
date
Maßeinheiten
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C2032736
- UMLS CUI [1,2]
- C2985720
Beschreibung
Treatment Area
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0205146
Beschreibung
Painful Area: Size
Datentyp
float
Maßeinheiten
- cm^2
Alias
- UMLS CUI [1,1]
- C2032736
- UMLS CUI [1,2]
- C0456389
Beschreibung
Dynamic Mechanical Allodynia
Alias
- UMLS CUI-1
- C2936719
Beschreibung
Dynamic Mechanical Allodynia
Datentyp
text
Alias
- UMLS CUI [1]
- C2936719
Beschreibung
Dynamic Mechanical Allodynia: Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0522510
Beschreibung
Dynamic Mechanical Allodynia: Size
Datentyp
float
Maßeinheiten
- cm^2
Alias
- UMLS CUI [1,1]
- C0522510
- UMLS CUI [1,2]
- C0456389
Beschreibung
Healthcare Resource Use
Alias
- UMLS CUI-1
- C1704738
Beschreibung
Healthcare Resource Use
Datentyp
text
Alias
- UMLS CUI [1]
- C1704738
Beschreibung
Number of contacts for Neuropathic Pains
Datentyp
float
Alias
- UMLS CUI [1,1]
- C1444281
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C3714625
Beschreibung
Number of contacts: Specification
Datentyp
float
Alias
- UMLS CUI [1,1]
- C1444281
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C2348235
Beschreibung
Application of Topical Anesthetic
Alias
- UMLS CUI-1
- C0185125
- UMLS CUI-2
- C0040464
Beschreibung
Application of Topical Anesthetic
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0185125
- UMLS CUI [1,2]
- C0040464
Beschreibung
Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Medication Dose
Datentyp
float
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Dose Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C2826646
Beschreibung
Application route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Start Date
Datentyp
date
Maßeinheiten
- dd/MMM/yyyy
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Start Time
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1]
- C1301880
Beschreibung
Stop Time
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1]
- C1522314
Beschreibung
Application of Qutenza
Alias
- UMLS CUI-1
- C0185125
- UMLS CUI-2
- C2725082
Beschreibung
Qutenza: Start Date
Datentyp
date
Maßeinheiten
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C2725082
- UMLS CUI [1,2]
- C0808070
Beschreibung
Qutenza: Start Time
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C2725082
- UMLS CUI [1,2]
- C1301880
Beschreibung
Qutenza: Stop Time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2725082
- UMLS CUI [1,2]
- C1522314
Beschreibung
Qutenza: Treatment Area
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2725082
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0205146
Beschreibung
Qutenza: Treatment Area Size
Datentyp
float
Maßeinheiten
- cm^2
Alias
- UMLS CUI [1,1]
- C2725082
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0205146
- UMLS CUI [1,4]
- C0456389
Beschreibung
Qutenza: Visual Estimated Percentage
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C2725082
- UMLS CUI [1,2]
- C0750572
- UMLS CUI [1,3]
- C0439165
Beschreibung
Qutenza: Treatment Patch Number
Datentyp
float
Alias
- UMLS CUI [1,1]
- C2725082
- UMLS CUI [1,2]
- C0991556
- UMLS CUI [1,3]
- C0449788
Beschreibung
Qutenza: Treatment Patch Percentage
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C2725082
- UMLS CUI [1,2]
- C0991556
- UMLS CUI [1,3]
- C0439165
Beschreibung
Tolerability Assessment
Alias
- UMLS CUI-1
- C3274448
Ähnliche Modelle
Baseline Visit QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
C1512693 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2,1])
C2985720 (UMLS CUI [2,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,2])
C1409616 (UMLS CUI [1,3])
C0392747 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C2985720 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0040464 (UMLS CUI-2)
C0040464 (UMLS CUI [1,2])
C2725082 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
C0750572 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0991556 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0991556 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])