Controlled Trial of High-Concentration Capsaicin Patch for Treatment of. NGX-4010 for the Treatment of Postherpetic Neuralgia. NGX-4010 (high-concentration capsaicin. NGX-4010 patch (high-concentration capsaicin). Qutenza (capsaicin) 8% patch. For more information about Qutenza. Do not sniff or inhale near the Qutenza patch as this may cause you to cough or sneeze. Accordingly, the recent introduction of a high concentration capsaicin patch for the treatment of neuropathic pain, which defunctionalizes. Long-Term Safety of NGX-4010, a High-Concentration Capsaicin Patch, in Patients with Peripheral Neuropathic Pain Simpson, David M.; Gazda, Suzanne; Brown, Stephen. Controlled trial of high-concentration capsaicin patch for. 16 NGX-4010, a high-concentration capsaicin. NGX-4010, a capsaicin 8% dermal patch. Malan P, Rauck R, Tobias J: NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. A Multicenter, Randomized, Double- Blind, Controlled Study of NGX- 4. High- Concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia. Abstract. Objectives. To confirm the efficacy, tolerability, and safety of NGX- 4. PHN is a chronic pain disorder that can be difficult to treat and for which current treatment options are often limited by poor tolerability. Design. A total of 4. NGX- 4. 01. 0 or a 0. Patients were 1. 8–9. PHN, pain for at least 6 months, and an average baseline Numeric Pain Rating Scale (NPRS) score of 3–9. Outcome Measures. The primary efficacy end point was the percentage change in NPRS score from baseline to weeks 2–8. Results. NGX- 4. 01. P = 0. 0. 11). Pain was significantly lower in NGX- 4. Most treatment- emergent adverse events were application site specific (notably erythema and pain), transient, and generally mild to moderate in severity. Conclusions. In patients with PHN, a single 6. NGX- 4. 01. 0 produced significant reduction in pain that was maintained over a 1. Neuropathic Pain. Postherpetic Neuralgia. Capsaicin. Introduction. Postherpetic neuralgia (PHN) is the most common complication of herpes zoster, which results from reactivation of latent varicella zoster virus that causes chicken pox. It is a chronic pain disorder that often leads to considerable disability and suffering. The definition of PHN varies, but it is typically defined as the presence of pain lasting more than 3 months from the onset of skin lesions . It is estimated that between 2. PHN . Common treatment options include anticonvulsants such as pregabalin and gabapentin, topical lidocaine, opioids, tricyclic antidepressants, and selective serotonin and norepinephrine reuptake inhibitors. However, the use of many of these treatments is often limited by poor tolerability, the need for titration, and administration of multiple daily doses. In addition, many patients continue to experience significant pain while taking these treatments . Because sensitization of peripheral nociceptors that express transient receptor potential vanilloid 1 receptor (TRPV1) is evident in many patients with PHN . Capsaicin activates TRPV1 ligand- gated cation channels on nociceptive nerve fibers, causing depolarization, action potential initiation, and the transmission of pain signals to the spinal cord. Continued capsaicin exposure leads to reversible defunctionalization of and associated decrease in epidermal TRPV1- expressing sensory nerve endings, inhibiting the initiation of pain transmission . NGX- 4. 01. 0 is a high- concentration capsaicin dermal patch (capsaicin, 8%) developed to quickly deliver a therapeutic dose of capsaicin locally into the skin during a single application. A dose- finding study in patients with PHN investigated the efficacy of NGX- 4. This dose was confirmed in a phase 3 study that demonstrated that a single 6. NGX- 4. 01. 0 significantly reduced pain in patients with PHN . The current study sought to confirm the results of the previous multicenter, randomized, double- blind, controlled phase 3 study that compared the efficacy and safety of a single 6. NGX- 4. 01. 0 with that of a low- concentration capsaicin control patch (capsaicin, 0. PHN . Patients were recruited directly by the study centers from their existing patient database, through written advertising, and radio and television ads. Patients 1. 8–9. 0 years old with a diagnosis of PHN and an average Numeric Pain Rating Scale (NPRS) . Patients taking chronic pain medications, such as anticonvulsants, non- SSRI antidepressants, opioids, nonsteroidal anti- inflammatory drugs (NSAIDS), salicylates, or acetaminophen, had to be on a stable dose of those medications for at least 2. Women of childbearing age were required to have a negative pregnancy test and be willing to use an effective method of contraception for 3. Exclusion criteria were as follows: use of any topically applied pain medication on the painful area within 2. PHN; painful PHN areas located only on the face, above the scalp hairline, or near mucous membranes; and hypersensitivity to capsaicin, local anesthetics, oxycodone hydrochloride, hydrocodone, or adhesives. As prior use of high- dose opioids could limit the responsiveness to the optional oral opioid analgesics for treatment- associated discomfort used during the treatment procedure, patients were excluded if they were using concomitant opioid medication that was not orally or transdermally administered, or exceeded a total dose of 6. The study was approved by the Institutional Review Boards/Independent Ethics Committees at all participating sites and conducted in accordance with the ethical principles of the Declaration of Helsinki, Good Clinical Practice guidelines, and applicable regulatory requirements. Written informed consent was obtained from all participating patients before initiating study- related procedures. Procedures. The double- blind study included a . Eligible patients were randomized 1: 1 to receive NGX- 4. Randomization was stratified by gender and cardiovascular risk status. The low- concentration capsaicin control patches were used in place of placebo patches to provide effective blinding in the study as topical capsaicin can produce local erythema and a burning sensation. The actual treatment assigned to individual patients was determined by a randomization scheme prepared by Fisher Clinical Services (Allentown, PA). Numbers were assigned only once, and no subject was randomized into the study more than once. The NGX- 4. 01. 0 and control patches were identical in appearance, as were the blinded study drug kits. Each kit was designated by a unique kit number, which was printed on the investigational drug label affixed to the outer bag enclosure and on each individual patch envelope. All patients were pretreated with a topical local anesthetic cream (LMX4. After patch removal, the area was cleansed with a proprietary cleansing gel formulated to remove residual capsaicin. Patients were monitored for 2 hours after patch removal. Local cooling as well as oxycodone hydrochloride oral solution (1 mg/m. L) or equivalent could be administered at the onset of treatment- associated discomfort and as needed. Patients could take short- acting opioid medication (hydrocodone bitartrate/acetaminophen 5 mg/5. Topical pain medications were not permitted during the 1. Patients were allowed to take acetaminophen up to 3 g/day as needed for aches and pains. Measures and Data Analysis. Efficacy. Efficacy was evaluated with daily NPRS scores captured at 9 pm every evening in a paper diary throughout the 1. The NPRS is an 1. These NPRS assessments were for “average pain for the past 2. Patient Global Impression of Change (PGIC; patients reported how they felt after treatment as compared with before treatment on a scale of . The modified Brief Pain Inventory (BPI) . Baseline NPRS scores were recorded from day . To avoid the potential confounding effect of allowed opioid medications for treatment- associated discomfort during days 0–5, week 1 NPRS scores were not included in the primary analysis. Other efficacy measures included: percentage change in NPRS scores from baseline to weeks 2–1. NPRS scores from baseline to weeks 2–8 and to weeks 2–1. NPRS score of . Efficacy analyses were based on the intent- to- treat population that consisted of all patients who received any study treatment and had at least 3 days of available NPRS scores during the baseline period. Mean percentage changes and mean numeric changes in NPRS scores from baseline to weeks 2 through 8 and 2 through 1. For each subject, the mean NPRS score for weeks 2 to n, where n is any number greater than 2, was computed as the average of the NPRS scores from day 8 to day 7 . Missing posttreatment NPRS scores were imputed using a modified last- observation- carried- forward approach. If the NPRS score was missing on any of days 0–8 or missing on day 8 and one or more consecutive days, then the baseline score was imputed for those days. If the NPRS score was missing for any day past day 8, then the missing score was imputed by the latest available non- missing score collected before that day. If all posttreatment NPRS scores were missing (including day 0), all scores were imputed using the baseline score. The percentage of responders (. A mixed- effect repeated measures ancova was used to analyze weekly percentage change from baseline in average pain. For the analysis of the weekly percentage change from baseline, no imputation was performed for missing pain scores posttreatment, as mixed- effects models allow the use of existing data without imputation. As a first step in the implementation of the repeated measures ancova, a full ancova that included gender, treatment, and week as main effects, two- way interactions and three- way interactions with baseline pain score as the covariate was performed to assess the effect of each treatment. Only the main effects and interactions that were statistically significant (P < 0. The main treatment effect, two- way interaction of gender with treatment, and treatment with week were significant and kept in the final model. Subject was included in the model as a random effect. The method took into consideration the week- to- week correlation of the pain score within the same subject assuming the autoregressive covariance structure. Such covariance structure was estimated from the data, which showed higher correlation in earlier weeks than that in later weeks up to week 1. The percentage of patients reporting PGIC/CGIC score improvement was compared between treatment groups using the Fisher exact test. Changes from screening in the BPI, SFMPQ, and SF- 3. It was estimated that to achieve 9. NPRS scores between the NGX- 4. Safety. Safety and tolerability assessments during the 1. Study of NGX- 4. 01. Treatment of Painful HIV- Associated Neuropathy - Full Text View. The C1. 07 study is a randomized, double- blind, controlled dose finding study of NGX- 4. HIV- associated neuropathy. Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and to receive double- blind NGX- 4. Participants who complete study evaluations through Week 1.
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