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The purpose of this study is to evaluate the safety and effectiveness of JNJ-42160443 in the treatment of moderate to severe neuropathic pain in patients with a diagnosis of diabetic painful neuropathy.
Chronic neuropathic pain (NP) is caused by diverse etiologies resulting in damage to the nervous system or dysfunction of the nervous system. Many common diseases, injuries, and interventions cause neuropathic pain by producing lesions in the peripheral or central nervous system. The current study is a randomized (study drug assigned by chance), double-blind (neither the study doctor nor the patient knows the name of the assigned drug), placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and tolerability of JNJ-42160443 in patients with diabetic painful neuropathy, followed by a double blind extension and an open-label (study doctor and patient knows the name of the study drug) extension. This study will evaluate the safety and effectiveness of JNJ-42160443 in the treatment of patients with moderate to severe, chronic, neuropathic pain that is not controlled with or without standard pain therapy and who have a diagnosis of diabetic painful neuropathy. The study has 5 phases: a screening phase of up to 35 days, a treatment phase of 12 weeks, an optional extension phase of up to 40 weeks, an optional extension phase of up to 52 weeks, and a follow-up phase of 26 weeks after the last dose of study medication. Eligible patients will receive one dose of study drug (JNJ-42160443 or placebo) given as an injection under the skin every 28 days during the 12-week treatment phase. Patients who complete the 12-week treatment phase will be eligible to enter the optional 40-week extension phase or complete the study. During the 40-week extension phase, patients will receive one dose of study drug (JNJ-42160443 or placebo) given as an injection under the skin every 28 days. Patients who complete the 40-week treatment phase will be eligible to enter the 52-week extension phase or complete the study. During the 52-week extension phase, patients will receive one dose of study drug (JNJ-42160443) given as an injection under the skin every 28 days. Assessments of effectiveness include assessment of daily average pain intensity, worst pain, Brief Pain Inventory, Neuropathic Pain Symptom Inventory, Patient Global Impression of Change, and other exploratory assessments (e.g., activity limitations). Safety assessments include physical examinations, neurologic examinations and evaluations, nerve conduction studies, skin biopsies, monitoring of adverse events, injection site evaluations, clinical laboratory evaluations, 12-lead electrocardiogram, and vital signs. The study hypothesis is that JNJ-42160443 will show a positive dose response relationship with respect to reducing average pain intensity in patients with moderate to severe, chronic neuropathic pain. Doses in the 12-week treatment and 40-week extension phases are Placebo, JNJ 42160443 1, 3, or 10 mg administered as a single, subcutaneous (SC) injection every 28 days. The doses for the 52-week extension phase will be up to 10 mg.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Published on BioPortfolio: 2014-07-23T21:12:30-0400
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