A5069835335- Pain Mechanisms and Treatments
- Botulinum Toxin and Related Neurological Disorders
- Healthcare and Venom Research
- Musculoskeletal pain and rehabilitation
- Herpesvirus Infections and Treatments
- Advancements in Transdermal Drug Delivery
- Pain Management and Placebo Effect
- Pharmacological Effects of Natural Compounds
- Health Systems, Economic Evaluations, Quality of Life
- Cancer Treatment and Pharmacology
- Meta-analysis and systematic reviews
- Spine and Intervertebral Disc Pathology
- Anesthesia and Pain Management
- Peripheral Neuropathies and Disorders
- Toxin Mechanisms and Immunotoxins
- Sepsis Diagnosis and Treatment
- Ultrasound and Hyperthermia Applications
- Neuropeptides and Animal Physiology
- Multiple Sclerosis Research Studies
- Pain Management and Treatment
- Vascular Malformations Diagnosis and Treatment
- Neonatal and Maternal Infections
- Ocular Surface and Contact Lens
- Meningioma and schwannoma management
- Fibromyalgia and Chronic Fatigue Syndrome Research
Jazz Pharmaceuticals (United States)
2014-2021
University of Rochester Medical Center
2021
Harvard University
2021
University of Washington
2021
American Chronic Pain Association
2020
Manila Consulting Group (United States)
2017
NeuroBioTex (United States)
2010-2013
Arizona Research Center
2013
University of Wisconsin–Madison
2010-2011
University of California, San Diego
2010
The expression and release of tissue factor is a major trigger for the activation coagulation in patients with sepsis. Tissue pathway inhibitor (TFPI) forms complex blood protease factors leading to inhibition thrombin generation fibrin formation.To determine if administration tifacogin (recombinant TFPI) provides mortality benefit severe sepsis elevated international normalized ratio (INR) assess safety sepsis, including low INR.A randomized, double-blind, placebo-controlled, multicenter,...
<b>Background: </b> HIV-associated distal sensory polyneuropathy (HIV-DSP) is a painful condition with limited effective treatment. Capsaicin desensitizes cutaneous nociceptors resulting in reduced pain. We report placebo-controlled study of high-concentration capsaicin dermal patch (NGX-4010) for the treatment HIV-DSP. <b>Methods: This double-blind multicenter randomized 307 patients HIV-DSP to receive NGX-4010 or control, low-concentration patch. After application topical anesthetic,...
A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority placebo conditions which their efficacy had previously been demonstrated. Assuming the validity previous evidence and comparability patients outcome measures these studies, such results may be a consequence limitations ability RCTs demonstrate benefits efficacious analgesic vs ("assay sensitivity"). Efforts improve assay sensitivity could reduce...
Objectives. To confirm the efficacy, tolerability, and safety of NGX-4010, an 8% capsaicin dermal patch (capsaicin 640 µg/cm2), in patients with postherpetic neuralgia (PHN). PHN is a chronic pain disorder that can be difficult to treat for which current treatment options are often limited by poor tolerability. Design. A total 418 were randomized receive single 60-minute application NGX-4010 or 0.04% control (3.2 µg/cm2) multicenter, double-blind, confirmatory, phase 3 study. Patients....
Objectives. To assess the efficacy, tolerability, and safety of NGX-4010, a high-concentration capsaicin dermal patch (capsaicin 640 μg/cm2, 8%) in patients with postherpetic neuralgia (PHN).
Abstract Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in practice. In this article, we report on an Initiative Methods, Measurement, and Pain Assessment Clinical Trials (IMMPACT) consensus meeting organized by Analgesic, Anesthetic, Addiction Trial Translations, Innovations, Opportunities, Networks, purpose which was recommend approaches that facilitate interpretation RCTs. We review issues consider when drawing...
Effective treatment of HIV-associated distal sensory polyneuropathy remains a significant unmet therapeutic need.In this randomized, double-blind, controlled study, patients with pain due to received single 30-minute or 60-minute application NGX-4010--a capsaicin 8% patch (n = 332)--or low-dose (0.04%) control 162). The primary endpoint was the mean percent change from baseline in Numeric Pain Rating Scale score weeks 2-12. Secondary endpoints included patient global impression at week...
HIV-associated distal sensory polyneuropathy (HIV-DSP) is the most frequently reported neurologic complication associated with HIV infection. NGX-4010 a capsaicin 8% dermal patch demonstrated efficacy in treatment of HIV-DSP. Data from two phase III, double-blind studies were integrated to further analyze and safety explore effect demographic baseline factors on similarly designed which patients HIV-DSP received or low-concentration control (capsaicin 0.04% w/w) for 30 60 minutes integrated....
Methods: This integrated analysis of tolerability data collected from the NGX-4010 clinical study program included 1696 patients with PNP. Patch application-related pain on treatment day was captured as Numeric Pain Rating Scale (NPRS) "pain now" scores while "average for past 24 hours" NPRS were analyzed 7 days following treatment. Other assessments percentage completing ≥90% intended duration and using medication patch pain. Results: The mean maximum change in pretreatment levels during...
Magnetic resonance (MR) imaging, the latest test for evaluation of patients with multiple sclerosis (MS), was assessed against clinical evidence in 74 definite or probable MS. MR imaging positive 55 (85%) 65 MS but only one (11%) nine The examination is most likely to be when patient classified clinically as having MS; disease active and not remission; if constellation symptoms indicates a multiplicity regions neurologic dysfunction. sensitive detecting lesions cerebral hemispheres,...
Abstract Background Postherpetic neuralgia (PHN) is a painful and difficult to treat complication of acute herpes zoster. Current treatment options provide only partial relief are often limited by poor tolerability. We evaluated the safety efficacy single 60-minute application NGX-4010, an 8% capsaicin patch, in patients with PHN. Methods This multicenter, double-blind, controlled study randomized 155 2:1 receive either NGX-4010 or 0.04% control patch. Patients were at least 18 years old PHN...
To evaluate the efficacy, safety, and tolerability of repeated NGX-4010 treatments in open-label extension phase a 52-week study patients with neuropathic pain due to HIV-associated distal sensory polyneuropathy (HIV-DSP).Patients completing 12-week, randomized, double-blind could enter 40-week, phase, receive up 3, 60-minute treatments. Patients recorded their "average for past 24 hours" daily using Numeric Pain Rating Scale (NPRS). Efficacy assessment included percentage NPRS score...
Objective To evaluate in Gram-negative sepsis patients the human monoclonal immunoglobulin M antibody (MAB-T88) directed at enterobacterial common antigen which is a specific surface closely linked to lipopolysaccharide and shared by all members of Enterobacteriaceae family bacteria. Design Prospective, randomized, double-blinded, placebo-controlled, multicenter trial. Setting Thirty-three academic medical centers United States. Patients were entered with clinical diagnosis sepsis, presence...