A MULTICENTER RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF NGX-4010 FOR THE TREATMENT OF PAINFUL HIV-ASSOCIATED NEUROPATHY - C119
- Conditions
- Treatment of painful HIV-associated neuropathyMedDRA version: 8.1Level: PTClassification code 10054095Term: Neuropathic pain
- Registration Number
- EUCTR2006-002185-19-GB
- Lead Sponsor
- eurogesX Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 480
1. At least 18 years of age.
2. Documented evidence of HIV-1 infection.
3. Documented baseline diagnosis of painful HIV-associated distal symmetric polyneuropathy resulting from HIV disease and/or antiretroviral drug exposure (see protocol)
4. Average NPRS scores for HIV-AN associated pain during screening period of 3 to 9, inclusive. NPRS means Numeric Pain Rating Scale
5. Life expectancy of 12 months or longer per Investigator’s judgment
6. Intact, unbroken skin over the painful areas to be treated.
7. 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 the study.
8.Female subjects with child-bearing potential must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test, to be performed within 7 days of the 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).
9. 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 extensive travel during study participation.)
10. Subjects must sign an informed consent form for this study approved by the Investigator’s Institutional Review Board/Independent Ethics Committee (IRB/IEC).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 80 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose.
2. 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 the Investigator.
3. 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 the investigator.
4. 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.
5. Have started or stopped treatment with one or more neurotoxic antiretroviral agents (i.e., didanosine [ddI], zalcitabine [ddC], or stavudine [d4T] during the eight weeks prior to Day 0.
6. Participation in a previous NeurogesX clinical trial in which subject received NGX-4010 (either blinded or open-label study treatment).
7. Current use of any investigational agent, or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).
8. Evidence of another contributing cause for peripheral neuropathy, e.g., current uncontrolled diabetes mellitus (HbA1c = 9%) or a history of diabetes mellitus preceding the onset of HIV-AN; hereditary neuropathy; vitamin B12 deficiency (B12 level = 200 pg/mL at screening); or treatment within 90 days prior to Screening Visit with any drug that may have contributed to the sensory neuropathy.
9. Hypertension, unless adequately controlled by medication.
10. Significant pain of an etiology other than painful HIV-AN, for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis. Subjects must not have significant ongoing pain from other cause(s) that may interfere with judging HIV-AN related pain.
11. Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
12. Hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, opioid-based oral analgesics, or adhesives.
13. Significant medical abnormalities or conditions, including active malignancy defined as treatment required in the last five (5) years, that in the opinion of the investigator would interfere either with the ability to complete the study or the evaluation of AEs.
14. Recent history of a significant medical-surgical intervention that in the judgment of the Investigator would interfere either with the ability to complete the study or the evaluation of AEs; examples include but are not limited to major surgery, or receipt of immunosuppressive therapy within 3 months prior to the Study Patch Application Visit [Day 0].
15. Evidence of cognitive impairment including dementia that may interfere with subject’s ability to complete daily pain diaries requiring subject’s recall of average HIV-AN pain level in the past 24 hours.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy over 12 weeks of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy <br>;Secondary Objective: To assess the safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy ;Primary end point(s): The primary efficacy endpoint is the percent change from baseline in the average pain for the past 24 hours” NPRS score during Weeks 2–12. <br>NPRS means Numeric Pain Rating Scale
- Secondary Outcome Measures
Name Time Method