Information:
Error:
ID
41982
Description
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
Versions (2)
- 7/31/16 7/31/16 -
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on
March 15, 2021
DOI
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License
Creative Commons BY-NC-ND 3.0
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Screening Information QTZ-EC-0004 ELEVATE NCT01713426
Screening Information QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Similar models
Screening Information QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Screen failure
Item
Is the subject a screen failure (signed an informed consent but was not randomized/ registered)? If Yes, please provide the eason.
boolean
C0220908 (UMLS CUI [1,1])
C0680095 (UMLS CUI [1,2])
C0680095 (UMLS CUI [1,2])
Item
Primary Screen Failure Reason
text
C0220908 (UMLS CUI [1,1])
C0680095 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0680095 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
CL Item
Not Fulfilling Inculsion Criteria or Exclusion Criteria (Not Fulfilling Inculsion Criteria or Exclusion Criteria)
CL Item
Adverse Event (Adverse Event)
CL Item
Lost to Follow-Up (Lost to Follow-Up)
CL Item
Withdrawal by subject (Withdrawal by subject)
CL Item
Pregnancy (Pregnancy)
CL Item
Other (Other)
Screen Failure: Inclusion or Exclusion Criteria
Item
If "Not fulfill inclusion or exclusion criteria" is selected, please indicate the appropriate incusion or exclusion criteria number:
text
C0220908 (UMLS CUI [1,1])
C0680095 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0220908 (UMLS CUI [2,1])
C0680095 (UMLS CUI [2,2])
C0680251 (UMLS CUI [2,3])
C0680095 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0220908 (UMLS CUI [2,1])
C0680095 (UMLS CUI [2,2])
C0680251 (UMLS CUI [2,3])
Screen Failure: Specification
Item
If Primary Screen Failure Reason is "Other" please specify:
text
C0220908 (UMLS CUI [1,1])
C0680095 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0680095 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Date of Informed Consent
Item
Date of Informed Consent
date
C2985782 (UMLS CUI [1])
Sex
Item
Sex
text
C0079399 (UMLS CUI [1])
Patient Birth Date
Item
Birth Date
date
C0421451 (UMLS CUI [1])
Age
Item
Age
float
C0001779 (UMLS CUI [1])
CL Item
White (White)
CL Item
Black or African American (Black or African American)
CL Item
Asian (Asian)
CL Item
American Indian or Alaska Native (American Indian or Alaska Native)
CL Item
Native hawaiian or other Pacific Islander (Native hawaiian or other Pacific Islander)
CL Item
Other (Other)
Ethnic group: Specification
Item
If "Other", specify:
text
C0015031 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Employed, full time (Employed, full time)
CL Item
Employed, part time (Employed, part time)
CL Item
unemployed (unemployed)
CL Item
Other (Other)
Employment status: specification
Item
If "Other", specify:
text
C0242271 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Eligibility: Inclusion
Item
Is the subject fully eligible per the Inclusion Criteria?
boolean
C0013893 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,2])
Eligibility: Inclusion Specification
Item
If No, please list each Inclusion Criterion not met that makes the subject ineligible by adding as many log lines necessary:
text
C0013893 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
1. Male or female between 18 and 90 years of age, inclusive. (1. Male or female between 18 and 90 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 minimum of 3 months (5b. PNI including post-surgical or post-traumatic neuropathic pain, persisting for 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 polyneuropathy, based on clinical history and examination (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 polyneuropathy, based on clinical history and examination)
CL Item
6. Average pain score ≥ 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 ≥ 4 during screening period, over a minimum of at least 4 consecutive days (using the "average pain for the past 24 hours" (NPRS) 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. Naive to treatment with pregabalin and gabapentin (8a. Naive 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)
Eligibility: Exclusion
Item
Is the subject fully eligible per the Exclusion Criteria?
boolean
C0013893 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
Eligibility: Exclusion Specification
Item
If No, please list each Exclusion Criterion that makes the subject ineligible by adding as many log lines necessary.
text
C0013893 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0680251 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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 athritis (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 athritis)
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) < 60 mL/ min according to the Cockcroft-Gault formula (9. Creatinine clearance (CLcr) < 60 mL/ 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 or 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 or 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.)