ID

16700

Descrizione

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

Keywords

  1. 01/08/16 01/08/16 -
Caricato su

1 agosto 2016

DOI

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Licenza

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

Date of Visit
Descrizione

Date of Visit

Alias
UMLS CUI-1
C1320303
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.)
Descrizione

Visit

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0545082
If Yes, please provide the Date of Visit.
Descrizione

Date of visit

Tipo di dati

date

Unità di misura
  • dd/MMM/yyyy
dd/MMM/yyyy
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Is the subject fully eligible per the Inclusion Criteria?
Descrizione

Eligibility: Inclusion

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C1512693
If No, please list each Inclusion Criterion not met that makes the subject ineligible by adding as many log lines necessary.
Descrizione

Inclusion Criteria

Tipo di dati

text

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
is the subject fully eligible per the Exclusion Criteria?
Descrizione

Eligibility: Exclusion

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C0680251
If No, please list each Exclusion Criterion that makes the subject ineligible by adding as many log lines necessary.
Descrizione

Exclusion Criteria

Tipo di dati

text

Alias
UMLS CUI [1]
C0680251
Physical Examination
Descrizione

Physical Examination

Alias
UMLS CUI-1
C0031809
Form Not Done
Descrizione

Physical Examination

Tipo di dati

text

Alias
UMLS CUI [1]
C0031809
Assessment Date
Descrizione

Assessment Date

Tipo di dati

date

Unità di misura
  • dd/MMM/yyyy
Alias
UMLS CUI [1]
C2985720
dd/MMM/yyyy
Record any abnormal findings/ conditions identified during the exam on the appropriate form. For Screening/ Baseline visits, report abnormal findings/ conditions on the appropriate form (Medical History or Adverse Events). For Post-Baseline visits, record abnormal findings/ conditions that have worsened from Screening/ Baseline and are clinically significant on the Adverse Events form.
Descrizione

Physical Examination: Comment

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0947611
Vital signs
Descrizione

Vital signs

Alias
UMLS CUI-1
C0518766
Form Not Done
Descrizione

Vital signs

Tipo di dati

text

Alias
UMLS CUI [1]
C0518766
Scheduled Time (Within 15 minutes before topical anaesthetic application)
Descrizione

Scheduled Time

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0086960
Assessment Date
Descrizione

Vital signs: Assessment Date

Tipo di dati

date

Unità di misura
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2985720
dd/MMM/yyyy
Assessment Time (00:00 - 23:59)
Descrizione

Vital signs: Assessment Time

Tipo di dati

time

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

Position

Tipo di dati

text

Systolic Blood Pressure
Descrizione

Systolic Blood Pressure

Tipo di dati

float

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descrizione

Diastolic Blood Pressure

Tipo di dati

float

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Descrizione

Pulse

Tipo di dati

float

Unità di misura
  • Beats/Min
Alias
UMLS CUI [1]
C0232117
Beats/Min
Record any abnormal results on the appropriate form. For Screening/ Baseline visits, report abnormal resutls on the appropriate form (Medical History or Adverse Events). For Post-Baseline visits, record abnormal results that have worsened from Screening/ Baseline and are clinically significant on the Adverse Events form.
Descrizione

Vitals signs: Comment

Tipo di dati

text

Unità di misura
  • hh:mm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0947611
hh:mm
Height and Weight
Descrizione

Height and Weight

Alias
UMLS CUI-1
C0005890
UMLS CUI-2
C0005910
Form Not Done
Descrizione

Height and Weight

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C0005910
Assessment Date
Descrizione

Height and Weight: Assessment Date

Tipo di dati

date

Unità di misura
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C2985720
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C2985720
dd/MMM/yyyy
Height
Descrizione

Height

Tipo di dati

float

Unità di misura
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descrizione

Weight

Tipo di dati

float

Unità di misura
  • kg
Alias
UMLS CUI [1]
C0005910
kg
BMI
Descrizione

BMI

Tipo di dati

text

Unità di misura
  • kg/m^2
Alias
UMLS CUI [1]
C1305855
kg/m^2
Pregnancy Test
Descrizione

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Form Not Done (Mark Form Not Done only if the entire visit was not done, otherwise provide details below)
Descrizione

Pregnancy Test

Tipo di dati

text

Alias
UMLS CUI [1]
C0032976
If Pregnancy Test was not done, please provide reason:
Descrizione

Pregnancy Test: Reason

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0392360
If `Other`, specify:
Descrizione

Pregnancy Test: Reason Specification

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2348235
Date of Sample Taken
Descrizione

Pregnancy Test: Date

Tipo di dati

date

Unità di misura
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
dd/MMM/yyyy
Result of Pregnancy Test
Descrizione

Pregnancy Test: Result

Tipo di dati

text

Alias
UMLS CUI [1]
C0427777
Randomization
Descrizione

Randomization

Alias
UMLS CUI-1
C0034656
Date of Randomization
Descrizione

Date of Randomization

Tipo di dati

date

Unità di misura
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
dd/MMM/yyyy
Assigned Treatment Group
Descrizione

Treatment Group

Tipo di dati

text

Alias
UMLS CUI [1]
C1522541
Date of First Study Drug Taken
Descrizione

Date of First Study Drug Taken

Tipo di dati

date

Unità di misura
  • dd/MMM/yyyy
Alias
UMLS CUI [1]
C3899436
dd/MMM/yyyy
Painful Area: Change
Descrizione

Painful Area: Change

Alias
UMLS CUI-1
C2032736
UMLS CUI-2
C0392747
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
Descrizione

Painful Area

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2032736
UMLS CUI [1,2]
C0392747
Is there any change in the painful area since Screening visit?
Descrizione

Painful Area: Change since Screening visit

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2032736
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C1409616
If "Yes", please provide details on "Identifacation of Painful Area".
Descrizione

Painful Area: Change Specification

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2032736
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C2348235
Painful Area
Descrizione

Painful Area

Alias
UMLS CUI-1
C2032736
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
Descrizione

Painful Area

Tipo di dati

text

Alias
UMLS CUI [1]
C2032736
Assessment Date
Descrizione

Painful Area: Assessment Date

Tipo di dati

date

Unità di misura
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C2032736
UMLS CUI [1,2]
C2985720
dd/MMM/yyyy
Treatment area: Plase tick all that apply
Descrizione

Treatment Area

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205146
Total Painful/ Sensitive area Size
Descrizione

Painful Area: Size

Tipo di dati

float

Unità di misura
  • cm^2
Alias
UMLS CUI [1,1]
C2032736
UMLS CUI [1,2]
C0456389
cm^2
Dynamic Mechanical Allodynia
Descrizione

Dynamic Mechanical Allodynia

Alias
UMLS CUI-1
C2936719
Form Not Done
Descrizione

Dynamic Mechanical Allodynia

Tipo di dati

text

Alias
UMLS CUI [1]
C2936719
Intensity of dynamic mechanical allodynia (0=No Pain; 10=Pain as bad as patient can imagine)
Descrizione

Dynamic Mechanical Allodynia: Intensity

Tipo di dati

integer

Alias
UMLS CUI [1]
C0522510
Total surface area size of area of dynamic mechanical allodynia
Descrizione

Dynamic Mechanical Allodynia: Size

Tipo di dati

float

Unità di misura
  • cm^2
Alias
UMLS CUI [1,1]
C0522510
UMLS CUI [1,2]
C0456389
cm^2
Healthcare Resource Use
Descrizione

Healthcare Resource Use

Alias
UMLS CUI-1
C1704738
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
Descrizione

Healthcare Resource Use

Tipo di dati

text

Alias
UMLS CUI [1]
C1704738
Number of contacts with a healthcare professional related to neuropathic pain, since the last visit
Descrizione

Number of contacts for Neuropathic Pains

Tipo di dati

float

Alias
UMLS CUI [1,1]
C1444281
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C3714625
Number of contacts with a healthcare professional for other causes, since the last visit
Descrizione

Number of contacts: Specification

Tipo di dati

float

Alias
UMLS CUI [1,1]
C1444281
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C2348235
Application of Topical Anesthetic
Descrizione

Application of Topical Anesthetic

Alias
UMLS CUI-1
C0185125
UMLS CUI-2
C0040464
Form Not Done
Descrizione

Application of Topical Anesthetic

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0185125
UMLS CUI [1,2]
C0040464
Medication
Descrizione

Medication

Tipo di dati

text

Alias
UMLS CUI [1]
C0013227
Dose
Descrizione

Medication Dose

Tipo di dati

float

Alias
UMLS CUI [1]
C3174092
Dose Unit
Descrizione

Dose Unit

Tipo di dati

text

Alias
UMLS CUI [1]
C2826646
Route
Descrizione

Application route

Tipo di dati

text

Alias
UMLS CUI [1]
C0013153
Start Date
Descrizione

Start Date

Tipo di dati

date

Unità di misura
  • dd/MMM/yyyy
Alias
UMLS CUI [1]
C0808070
dd/MMM/yyyy
Start Time (00:00 - 23:59)
Descrizione

Start Time

Tipo di dati

time

Unità di misura
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
Stop Time (00:00 - 23:59)
Descrizione

Stop Time

Tipo di dati

time

Unità di misura
  • hh:mm
Alias
UMLS CUI [1]
C1522314
hh:mm
Application of Qutenza
Descrizione

Application of Qutenza

Alias
UMLS CUI-1
C0185125
UMLS CUI-2
C2725082
Start Date
Descrizione

Qutenza: Start Date

Tipo di dati

date

Unità di misura
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C2725082
UMLS CUI [1,2]
C0808070
dd/MMM/yyyy
Start Time (00:00 - 23:59) (Start time is when first patch is applied)
Descrizione

Qutenza: Start Time

Tipo di dati

time

Unità di misura
  • hh:mm
Alias
UMLS CUI [1,1]
C2725082
UMLS CUI [1,2]
C1301880
hh:mm
Stop Time (00:00 - 23:59) (When all study patches have been removed, record the time of patch removal)
Descrizione

Qutenza: Stop Time

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2725082
UMLS CUI [1,2]
C1522314
Treatment Area
Descrizione

Qutenza: Treatment Area

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2725082
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205146
Treatment Area Size
Descrizione

Qutenza: Treatment Area Size

Tipo di dati

float

Unità di misura
  • cm^2
Alias
UMLS CUI [1,1]
C2725082
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205146
UMLS CUI [1,4]
C0456389
cm^2
Visual Estimate of % used for each patch (0 - 100%)
Descrizione

Qutenza: Visual Estimated Percentage

Tipo di dati

float

Unità di misura
  • %
Alias
UMLS CUI [1,1]
C2725082
UMLS CUI [1,2]
C0750572
UMLS CUI [1,3]
C0439165
%
Treatment Patch No. (1 - 4)
Descrizione

Qutenza: Treatment Patch Number

Tipo di dati

float

Alias
UMLS CUI [1,1]
C2725082
UMLS CUI [1,2]
C0991556
UMLS CUI [1,3]
C0449788
Treatment Patch Percentage
Descrizione

Qutenza: Treatment Patch Percentage

Tipo di dati

float

Unità di misura
  • %
Alias
UMLS CUI [1,1]
C2725082
UMLS CUI [1,2]
C0991556
UMLS CUI [1,3]
C0439165
%
Tolerability Assessment
Descrizione

Tolerability Assessment

Alias
UMLS CUI-1
C3274448
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG").
Descrizione

Tolerability Assessment

Tipo di dati

text

Alias
UMLS CUI [1]
C3274448
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
Descrizione

Adverse Event

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0877248

Similar models

Baseline Visit QTZ-EC-0004 ELEVATE NCT01713426

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Visit
Item
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.)
boolean
C0545082 (UMLS CUI [1])
Date of visit
Item
If Yes, please provide the Date of Visit.
date
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Eligibility: Inclusion
Item
Is the subject fully eligible per the Inclusion Criteria?
boolean
C0013893 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Item
If No, please list each Inclusion Criterion not met that makes the subject ineligible by adding as many log lines necessary.
text
C1512693 (UMLS CUI [1])
Code List
If No, please list each Inclusion Criterion not met that makes the subject ineligible by adding as many log lines necessary.
CL Item
1.Male or female between 18 and 80 years of age, inclusive (1.Male or female between 18 and 80 years of age, inclusive)
CL Item
2. In good health as determined by the investigator (2. In good health as determined by the investigator)
CL Item
3. Documented diagnosis of probable or definite PNP (Treede et al, 2008) (3. Documented diagnosis of probable or definite PNP (Treede et al, 2008))
CL Item
4. Localized and well-defined area of PNP, suitable for treatment with QUTENZA (4. Localized and well-defined area of PNP, suitable for treatment with QUTENZA)
CL Item
5a. Documented diagnosis at the Baseline Visit of either: a. PHN with pain persisting at least 6 months since shingles vesicle crusting (5a. Documented diagnosis at the Baseline Visit of either: a. PHN with pain persisting at least 6 months since shingles vesicle crusting)
CL Item
5b. PNI including post-surgical or post-traumatic neuropathic pain, persisting for a minimum of 3 months (5b. PNI including post-surgical or post-traumatic neuropathic pain, persisting for a minimum of 3 months)
CL Item
5c. Non-diabetic painful peripheral polyneuropathy with pain which has persisted for a minimum of 3 months, including I. small-fiber neuropathy, as confirmed by QST, laser evoked potentials (LEP), or skin biopsy, II. chemotherapy induced neuropathy in subjects with stable neoplastic disease, III. other, adequately characterized painful peripheral (5c. Non-diabetic painful peripheral polyneuropathy with pain which has persisted for a minimum of 3 months, including I. small-fiber neuropathy, as confirmed by QST, laser evoked potentials (LEP), or skin biopsy, II. chemotherapy induced neuropathy in subjects with stable neoplastic disease, III. other, adequately characterized painful peripheral)
CL Item
polyneuropathy, based on clinical history and examination (polyneuropathy, based on clinical history and examination)
CL Item
4 during screening period, over a minimum of at least 4 consecutive days (using the “average pain for the past 24 hours” (NPRS) score (6. Average pain score >)
CL Item
7. Intact, non-irritated, dry skin over the painful area(s) to be treated (7. Intact, non-irritated, dry skin over the painful area(s) to be treated)
CL Item
8a. Naïve to treatment with pregabalin and gabapentin (8a. Naïve to treatment with pregabalin and gabapentin)
CL Item
8b. In the opinion of the investigator, has not received an adequate trial of treatment with pregabalin or gabapentin (8b. In the opinion of the investigator, has not received an adequate trial of treatment with pregabalin or gabapentin)
CL Item
9. Subject is willing to receive pregabalin or QUTENZA as part of the trial. (9. Subject is willing to receive pregabalin or QUTENZA as part of the trial.)
CL Item
10. Females of child bearing potential must be willing to use highly effective methods of birth control during the study and for 30 days following study termination (a highly effective method of birth control is defined as those which result in a low failure rate (CHMP/ICH/286/95 modified) of less that 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner). (10. Females of child bearing potential must be willing to use highly effective methods of birth control during the study and for 30 days following study termination (a highly effective method of birth control is defined as those which result in a low failure rate (CHMP/ICH/286/95 modified) of less that 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner).)
CL Item
11. Willing and able to comply with protocol requirements for the duration of study participation (11. Willing and able to comply with protocol requirements for the duration of study participation)
CL Item
12. Given written informed consent (12. Given written informed consent)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Eligibility: Exclusion
Item
is the subject fully eligible per the Exclusion Criteria?
boolean
C0013893 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Item
If No, please list each Exclusion Criterion that makes the subject ineligible by adding as many log lines necessary.
text
C0680251 (UMLS CUI [1])
Code List
If No, please list each Exclusion Criterion that makes the subject ineligible by adding as many log lines necessary.
CL Item
1. Significant ongoing or recurrent pain of etiology other than PHN, PNI or non-diabetic painful peripheral polyneuropathy, for example: compression-related neuropathies (e.g. spinal stenosis), radiculopathy, tumor related pain, fibromyalgia or arthritis (1. Significant ongoing or recurrent pain of etiology other than PHN, PNI or non-diabetic painful peripheral polyneuropathy, for example: compression-related neuropathies (e.g. spinal stenosis), radiculopathy, tumor related pain, fibromyalgia or arthritis)
CL Item
2. Complex Regional Pain Syndrome (CRPS, Type I or II) (2. Complex Regional Pain Syndrome (CRPS, Type I or II))
CL Item
3. Neuropathic pain related to previously administered radiotherapy, diabetes mellitus or HIV-AN (3. Neuropathic pain related to previously administered radiotherapy, diabetes mellitus or HIV-AN)
CL Item
4. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes (4. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes)
CL Item
5. Severe loss of heat sensation in the painful area, indicative of C-fiber denervation (5. Severe loss of heat sensation in the painful area, indicative of C-fiber denervation)
CL Item
6. Reported daily pain score of 10 on the NPRS for at least 4 days during the screening period (6. Reported daily pain score of 10 on the NPRS for at least 4 days during the screening period)
CL Item
7. Past or current history of diabetes mellitus. (7. Past or current history of diabetes mellitus.)
CL Item
8. Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the subject at risk of adverse cardiovascular reactions related to the patch application procedure (8. Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the subject at risk of adverse cardiovascular reactions related to the patch application procedure)
CL Item
9. Creatinine clearance (CLcr) < 60mL/min according to the Cockcroft-Gault formula (9. Creatinine clearance (CLcr) < 60mL/min according to the Cockcroft-Gault formula)
CL Item
10. Untreated ongoing generalized anxiety disorder according to DSM-IV or ICD-10 criteria (10. Untreated ongoing generalized anxiety disorder according to DSM-IV or ICD-10 criteria)
CL Item
11. Severe ongoing depression according to DSM-IV or ICD-10 criteria (11. Severe ongoing depression according to DSM-IV or ICD-10 criteria)
CL Item
12. Evidence of cognitive impairment including dementia that may interfere with subject’s ability to complete study evaluations and recall pain levels in the past 24 hours (12. Evidence of cognitive impairment including dementia that may interfere with subject’s ability to complete study evaluations and recall pain levels in the past 24 hours)
CL Item
13. Planned elective surgery during the trial (13. Planned elective surgery during the trial)
CL Item
14. Changes to stable neuropathic pain background medication in the 4 weeks prior to the Baseline Visit (14. Changes to stable neuropathic pain background medication in the 4 weeks prior to the Baseline Visit)
CL Item
15. Any prior receipt of QUTENZA patches, including blinded patches administered as part of a clinical trial (15. Any prior receipt of QUTENZA patches, including blinded patches administered as part of a clinical trial)
CL Item
16. Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products), any QUTENZA excipients, local anesthetics, or adhesives (16. Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products), any QUTENZA excipients, local anesthetics, or adhesives)
CL Item
17. Treatment with pregabalin or gabapentin within 2 months prior to the Baseline Visit. (17. Treatment with pregabalin or gabapentin within 2 months prior to the Baseline Visit.)
CL Item
18. Hypersensitivity to pregabalin or any of the excipients (18. Hypersensitivity to pregabalin or any of the excipients)
CL Item
19. Use of opioids exceeding a total daily dose of morphine of 200 mg/day, or equivalent o r any intravenous opioids or tapentadol, regardless of dose, within 7 days preceding the Baseline Visit. (19. Use of opioids exceeding a total daily dose of morphine of 200 mg/day, or equivalent o r any intravenous opioids or tapentadol, regardless of dose, within 7 days preceding the Baseline Visit.)
CL Item
20. Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including patch containing lidocaine), steroids or capsaicin products on the painful areas to be treated within 7 days preceding the Baseline Visit (20. Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including patch containing lidocaine), steroids or capsaicin products on the painful areas to be treated within 7 days preceding the Baseline Visit)
CL Item
21. Chemotherapy within 3 months of the Baseline Visit, except maintenance hormone treatment (21. Chemotherapy within 3 months of the Baseline Visit, except maintenance hormone treatment)
CL Item
22. Use of any investigational agent within 30 days prior to Baseline Visit (22. Use of any investigational agent within 30 days prior to Baseline Visit)
CL Item
23. Active substance abuse or history of chronic substance abuse within 1 year prior to screening; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator (23. Active substance abuse or history of chronic substance abuse within 1 year prior to screening; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator)
CL Item
24. Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment (24. Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment)
CL Item
25. Subject, who in th eopinion of the investigator, is not suitable for the study for any reason. (25. Subject, who in th eopinion of the investigator, is not suitable for the study for any reason.)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Form Not Done
text
C0031809 (UMLS CUI [1])
Code List
Form Not Done
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Physical Examination: Comment
Item
Record any abnormal findings/ conditions identified during the exam on the appropriate form. For Screening/ Baseline visits, report abnormal findings/ conditions on the appropriate form (Medical History or Adverse Events). For Post-Baseline visits, record abnormal findings/ conditions that have worsened from Screening/ Baseline and are clinically significant on the Adverse Events form.
text
C0031809 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Item
Form Not Done
text
C0518766 (UMLS CUI [1])
Code List
Form Not Done
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Scheduled Time
Item
Scheduled Time (Within 15 minutes before topical anaesthetic application)
boolean
C0086960 (UMLS CUI [1])
Vital signs: Assessment Date
Item
Assessment Date
date
C0518766 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Vital signs: Assessment Time
Item
Assessment Time (00:00 - 23:59)
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Position
text
Code List
Position
CL Item
Supine (Supine)
CL Item
Sitting (Sitting)
CL Item
Standing (Standing)
Systolic Blood Pressure
Item
Systolic Blood Pressure
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
float
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
float
C0232117 (UMLS CUI [1])
Vitals signs: Comment
Item
Record any abnormal results on the appropriate form. For Screening/ Baseline visits, report abnormal resutls on the appropriate form (Medical History or Adverse Events). For Post-Baseline visits, record abnormal results that have worsened from Screening/ Baseline and are clinically significant on the Adverse Events form.
text
C0518766 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Height and Weight
C0005890 (UMLS CUI-1)
C0005910 (UMLS CUI-2)
Item
Form Not Done
text
C0005890 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
Code List
Form Not Done
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Height and Weight: Assessment Date
Item
Assessment Date
date
C0005890 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2,1])
C2985720 (UMLS CUI [2,2])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
BMI
Item
BMI
text
C1305855 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Item
Form Not Done (Mark Form Not Done only if the entire visit was not done, otherwise provide details below)
text
C0032976 (UMLS CUI [1])
Code List
Form Not Done (Mark Form Not Done only if the entire visit was not done, otherwise provide details below)
CL Item
Done  (Done )
CL Item
Not Done (Not Done)
Item
If Pregnancy Test was not done, please provide reason:
text
C0032976 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If Pregnancy Test was not done, please provide reason:
CL Item
Female (2 years post-menopausal or surgically sterile) (Female (2 years post-menopausal or surgically sterile))
CL Item
Male (Male)
CL Item
Other (Other)
Pregnancy Test: Reason Specification
Item
If `Other`, specify:
text
C0032976 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Pregnancy Test: Date
Item
Date of Sample Taken
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of Pregnancy Test
text
C0427777 (UMLS CUI [1])
Code List
Result of Pregnancy Test
CL Item
Negative  (Negative )
CL Item
Positive (Positive)
Item Group
Randomization
C0034656 (UMLS CUI-1)
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Assigned Treatment Group
text
C1522541 (UMLS CUI [1])
Code List
Assigned Treatment Group
CL Item
Qutenza (Qutenza)
CL Item
Pregabalin (Pregabalin)
Date of First Study Drug Taken
Item
Date of First Study Drug Taken
date
C3899436 (UMLS CUI [1])
Item Group
Painful Area: Change
C2032736 (UMLS CUI-1)
C0392747 (UMLS CUI-2)
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
text
C2032736 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Painful Area: Change since Screening visit
Item
Is there any change in the painful area since Screening visit?
boolean
C2032736 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C1409616 (UMLS CUI [1,3])
Painful Area: Change Specification
Item
If "Yes", please provide details on "Identifacation of Painful Area".
text
C2032736 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Painful Area
C2032736 (UMLS CUI-1)
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
text
C2032736 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Painful Area: Assessment Date
Item
Assessment Date
date
C2032736 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Treatment area: Plase tick all that apply
text
C0087111 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
Code List
Treatment area: Plase tick all that apply
CL Item
Arms (Arms)
CL Item
Feet (Feet)
CL Item
Hands (Hands)
CL Item
Head and Neck (Head and Neck)
CL Item
Legs (Legs)
CL Item
Torso (Torso)
Painful Area: Size
Item
Total Painful/ Sensitive area Size
float
C2032736 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item Group
Dynamic Mechanical Allodynia
C2936719 (UMLS CUI-1)
Item
Form Not Done
text
C2936719 (UMLS CUI [1])
Code List
Form Not Done
CL Item
Done  (Done )
CL Item
Not Done (Not Done)
Item
Intensity of dynamic mechanical allodynia (0=No Pain; 10=Pain as bad as patient can imagine)
integer
C0522510 (UMLS CUI [1])
Code List
Intensity of dynamic mechanical allodynia (0=No Pain; 10=Pain as bad as patient can imagine)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
5 (6)
CL Item
6 (7)
CL Item
7 (8)
CL Item
8 (9)
CL Item
9 (10)
CL Item
10 (11)
Dynamic Mechanical Allodynia: Size
Item
Total surface area size of area of dynamic mechanical allodynia
float
C0522510 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item Group
Healthcare Resource Use
C1704738 (UMLS CUI-1)
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
text
C1704738 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Number of contacts for Neuropathic Pains
Item
Number of contacts with a healthcare professional related to neuropathic pain, since the last visit
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
Number of contacts: Specification
Item
Number of contacts with a healthcare professional for other causes, since the last visit
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Application of Topical Anesthetic
C0185125 (UMLS CUI-1)
C0040464 (UMLS CUI-2)
Item
Form Not Done
text
C0185125 (UMLS CUI [1,1])
C0040464 (UMLS CUI [1,2])
Code List
Form Not Done
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Medication
Item
Medication
text
C0013227 (UMLS CUI [1])
Medication Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Dose Unit
Item
Dose Unit
text
C2826646 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
Code List
Route
CL Item
Oral (Oral)
CL Item
Intravenous (Intravenous)
CL Item
Topical (Topical)
CL Item
Nasogastric (Nasogastric)
CL Item
Subcutaneous (Subcutaneous)
CL Item
Intramuscular (Intramuscular)
CL Item
Auricular (Otic) (Auricular (Otic))
CL Item
Ophthalmic (Ophthalmic)
CL Item
Sublingual (Sublingual)
CL Item
Respiratory (Inhalation) (Respiratory (Inhalation))
CL Item
Nasal (Nasal)
CL Item
Transdermal (Transdermal)
CL Item
Vaginal (Vaginal)
CL Item
Rectal (Rectal)
CL Item
Epidural (Epidural)
CL Item
Intrathecal (Intrathecal)
CL Item
Intra-Articular (Intra-Articular)
CL Item
Periarticular (Periarticular)
CL Item
Intraperitoneal (Intraperitoneal)
CL Item
Intradermal (Intradermal)
CL Item
Intra-arterial (Intra-arterial)
CL Item
Urethral (Urethral)
CL Item
Other (Other)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time (00:00 - 23:59)
time
C1301880 (UMLS CUI [1])
Stop Time
Item
Stop Time (00:00 - 23:59)
time
C1522314 (UMLS CUI [1])
Item Group
Application of Qutenza
C0185125 (UMLS CUI-1)
C2725082 (UMLS CUI-2)
Qutenza: Start Date
Item
Start Date
date
C2725082 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Qutenza: Start Time
Item
Start Time (00:00 - 23:59) (Start time is when first patch is applied)
time
C2725082 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Qutenza: Stop Time
Item
Stop Time (00:00 - 23:59) (When all study patches have been removed, record the time of patch removal)
text
C2725082 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Treatment Area
text
C2725082 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
Code List
Treatment Area
CL Item
Head and Neck (Head and Neck)
CL Item
Arms (Arms)
CL Item
Hands (Hands)
CL Item
Torso (Torso)
CL Item
Legs (Legs)
CL Item
Feet (Feet)
Qutenza: Treatment Area Size
Item
Treatment Area Size
float
C2725082 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Qutenza: Visual Estimated Percentage
Item
Visual Estimate of % used for each patch (0 - 100%)
float
C2725082 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Qutenza: Treatment Patch Number
Item
Treatment Patch No. (1 - 4)
float
C2725082 (UMLS CUI [1,1])
C0991556 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Qutenza: Treatment Patch Percentage
Item
Treatment Patch Percentage
float
C2725082 (UMLS CUI [1,1])
C0991556 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Item Group
Tolerability Assessment
C3274448 (UMLS CUI-1)
Item
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG").
text
C3274448 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG").
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Adverse Event
Item
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
boolean
C0877248 (UMLS CUI [1])

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