Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Brief Summary: The purpose of the study is to assess the efficacy, safety and tolerability of NGX 4010 applied for 60 minutes for the treatment of PHN.


Options:
A: Inclusion Criteria:

* Documented evidence of HIV-1 infection
* Documented diagnosis of painful HIV-associated distal symmetric polyneuropathy resulting from HIV disease and/or antiretroviral drug exposure To be confirmed based on symptoms of pain, burning or dysesthetic discomfort in both feet for at least 2 months prior to Screening Visit, AND absent or diminished ankle reflexes OR at least one of following: distal diminution of vibration sensation or pain or temperature sensation in legs
* Average NPRS scores during screening period of 3 to 9, inclusive
* Life expectancy of 12 months or longer per Investigator's judgment
* Intact, unbroken skin over painful areas to be treated
* If taking chronic pain medications, be on stable regimen for at least 21 days prior to Day 0 and willing to maintain medications at same stable dose(s) and schedule throughout study
* Female subjects with child-bearing potential: negative serum pregnancy test performed at Screening Visit
* Willing to use effective methods of birth control and/or refrain from conception process during study and for 30 days following study drug exposure
* Willing and able to comply with protocol for duration of study

Exclusion Criteria:

* Concomitant opioid medication, unless orally or transdermally administered and not exceeding total daily dose of morphine 80 mg/day or equivalent; parenteral opioids not allowed
* Unavailability of effective rescue medication strategy for subject, such as unwillingness to use opioid analgesics during study treatment or high tolerance to opioids precluding ability to relieve treatment-associated discomfort as judged by investigator
* Active substance abuse or history of chronic substance abuse within past year or prior chronic substance abuse (including alcoholism) judged likely to recur during study period by investigator
* Recent use (within 21 days preceding Day 0) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin products on painful areas
* Started or stopped treatment with one or more neurotoxic antiretroviral agents (ie, didanosine \[ddI\], zalcitabine \[ddC\], or stavudine \[d4T\] during 8 weeks prior to Day 0
* Participation in previous clinical trial in which subject received either blinded or open-label NGX-4010
* Current use of any investigational agent or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine)
* Evidence of another contributing cause for peripheral neuropathy, e.g., current uncontrolled diabetes mellitus (HbA1c≥9%) or history of diabetes mellitus preceding onset of HIV-associated neuropathy (HIV-AN); hereditary neuropathy; vitamin B12 deficiency (B12 level ≤200pg/mL at screening); or treatment within 90 days prior to Screening Visit with any drug that may have contributed to sensory neuropathy
* Hypertension, unless adequately controlled by medication
* Significant ongoing pain from other cause(s) that may interfere with judging HIV-AN related pain
* Any implanted medical device for treatment of neuropathic pain
* Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter (OTC) capsaicin products), local anesthetics, opioid-based oral analgesics or adhesives
* Significant medical conditions (including active malignancy defined as treatment required in last 5 years) that in opinion of investigator would interfere with ability to complete study or evaluation of AEs
* Recent significant medical-surgical intervention that in judgment of Investigator would interfere with ability to complete study or evaluation of AEs; examples include to major surgery, or receipt of immunosuppressive therapy within 3 months prior to Day 0
* Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring recall of average HIV-associated neuropathy pain level in past 24 hours
B: Inclusion Criteria:

* At least 18 years of age.
* Be in good health.
* Diagnosis of postherpetic neuralgia (PHN) made by the primary treating physician or Investigator, and at least 3 months post-vesicle crusting.
* Screening Pain Sum Score of 12 to 36.
* Intact, unbroken skin over the painful area(s) to be treated.
* If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Treatment Visit (Day 0) and willing to maintain medications at same stable dose(s) and schedule throughout the study.
* Female subjects with child-bearing potential must have a negative serum beta hCG pregnancy test, to be performed at the Screening Visit.
* All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following experimental drug exposure.
* Be willing and able to comply with protocol requirements for the duration of study participation. (Such requirements include, but are not limited to: completing a daily pain diary, attending all study visits, and refraining from elective surgery and extensive travel during study participation.)

Exclusion Criteria:

* Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose.
* Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with Roxicodone®, as judged by the Investigator.
* Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period by the investigator.
* Recent use (within 21 days preceding the Treatment Visit \[Day 0\]) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas.
* Current use of any investigational agent, or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).
* Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis) or fibromyalgia or arthritis. Subjects must not have significant ongoing pain from other cause(s) that may interfere with judging PHN-related pain.
* Painful PHN areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. (Investigational treatment with NGX-4010 is not allowed in these areas.)
* Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
* Hypersensitivity to capsaicin (i.e., chili peppers or Over-the-Counter (OTC) capsaicin products), local anesthetics, Roxicodone® or adhesives.
* Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events.
C: Inclusion Criteria:

* At least 18 years of age
* Documented evidence of HIV-1 infection
* Documented diagnosis of painful HIV-associated distal symmetrical polyneuropathy established by a neurologist resulting from HIV disease and/or antiretroviral drug exposure, with primary symptoms of pain, burning or dysesthetic discomfort in both feet for at least 2 months prior to Screening Visit, and absent or diminished ankle reflexes, and at least one of the following: distal diminution of vibration sensation or pain or temperature sensation in the legs
* Either no neurotoxic antiretroviral (didanosine, zalcitabine or stavudine) exposure for at least 8 weeks prior to Screening Visit, or currently on stable dose(s) of any neurotoxic antiretroviral(s) for at least 8 weeks prior to Screening Visit
* Screening Pain Sum Score of 12 to 36
* Karnofsky Performance Score of greater than or equal to 60
* Intact, unbroken skin over the painful area(s) to be treated
* If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Treatment Visit and willing to maintain these medications at the same stable dose(s) and schedule throughout the study
* Female subjects with child-bearing potential: negative serum pregnancy test performed at Screening Visit
* Willing to use effective methods of birth control and/or refrain from participating in a conception process during study and for 30 days following experimental drug exposure
* Willing and able to comply with protocol requirements for duration of study

Exclusion Criteria:

* Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose
* Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with Roxicodone® or Vicodin®, as judged by the Investigator
* Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period by the investigator
* Recent use (within 21 days preceding the Treatment Visit of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas
* Current use of any investigational agent or Class 1 anti-arrhythmic drugs
* Significant pain of an etiology other than painful HIV-associated neuropathy; significant ongoing pain from other cause(s) that may interfere with judging HIV-associated neuropathy pain
* Evidence of another contributing cause for peripheral neuropathy, e.g., diabetes mellitus requiring medication control (i.e., oral hypoglycemics, insulin); hereditary neuropathy; vitamin B12 deficiency (B12 level ≤ 200 pg/mL) or less than 3 months of B12 supplementation prior to Screening Visit; or treatment within 90 days prior to Screening Visit with any drug that may have contributed to the sensory neuropathy
* Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain
* Treatment for acute opportunistic infections within 14 days before Treatment Visit
* Presence of acute, active opportunistic infection, except oral thrush; oral, genital, or rectal herpes; and Mycobacterium avium bacteremia within 2 weeks prior to Screening Visit
* Currently have active malignant disease
* Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events
* Hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, Roxicodone®, Vicodin®, or adhesives
D: Inclusion Criteria:

* Diagnosis of PHN, with at least 6 months of pain since shingles vesicle crusting
* Average NPRS scores for PHN-associated pain during screening period of 3 to 9
* Intact, unbroken skin over the painful area(s) to be treated
* If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Study Patch Application Visit (Day 0) and willing to maintain medications at same stable dose(s) and schedule throughout study
* Female subjects with child-bearing potential must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test, within 7 days of Study Patch Application Visit
* All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study (or, in the event of early termination from the study, for 30 days following experimental drug exposure)
* Be willing and able to comply with protocol requirements for the duration of study participation.
* Subjects must sign an informed consent form for this study approved by the Investigator's Institutional Review Board/Independent Ethics Committee (IRB/IEC).

Exclusion Criteria:

* Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose.
* Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort, as judged by Investigator.
* Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism) judged likely to recur during the study period by Investigator.
* Recent use (within 21 days preceding the Study Patch Application Visit \[Day 0\]) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm (lidocaine patch 5%), steroids or capsaicin products on the painful areas.
* Participation in a previous NeurogesX clinical trial in which subject received NGX-4010 (either blinded or open-label study treatment).
* Current use of any investigational agent, or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).
* Diabetes mellitus, unless well-controlled as evidenced by an HbA1c level less than or equal to 9%.
* Hypertension, unless adequately controlled by medication.
* Significant pain of an etiology other than PHN. Subjects must not have significant ongoing pain from other cause(s) that may interfere with judging PHN-related pain.
* Painful PHN areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
* Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
* Hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, oxycodone hydrochloride, hydrocodone bitartrate or adhesives.
* Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events.
* Recent history of a significant medical-surgical intervention in the judgment of the Investigator.
* Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring subject's recall of average PHN pain level in the past 24 hours.

Answer: B