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)
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.)
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])
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])