Track topics on Twitter Track topics that are important to you
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
The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe knee or hip pain in pat...
The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain patients ...
A Trial to Study Pain Relief, Safety, and Tolerability of a New Treatment (JNJ-42160443) for Moderate to Severe Pain of Osteoarthritis of the Knee in Comparison to a Standard Pain Treatment and Placebo
A controlled, double-blind study evaluating pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison ...
The purpose of this study is to compare the safety and effectiveness of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe cancer-related pain in terminally ill pati...
The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of JNJ-42160443 compared to placebo in patients with moderate to severe, chronic bladder pain from...
Placebo hypoalgesia has been found to play an important role in every health care by modulating patients' responses to pharmacologically active analgesic treatments. It may be seen as reflecting the c...
Placebo and nocebo effects are currently within the focus of clinical and experimental pain research. Neurophysiological and psychophysiological mechanisms might play an important role. Placebo and no...
Placebo effects can be very effective in certain pain conditions, but their use is still highly controversial. Several studies show that patients would accept a placebo treatment under certain circums...
The placebo effect is considered the core example of mind-body interactions. However, individual differences produce large placebo response variability in both healthy volunteers and patients. The pla...
The development of new strategies to attenuate exercise-induced muscle damage may be helpful for training regimens. The aim of this study was to determine whether a oral formulation of angiotensin Ang...
A type of pain that is perceived in an area away from the site where the pain arises, such as facial pain caused by lesion of the VAGUS NERVE, or throat problem generating referred pain in the ear.
Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Dull or sharp aching pain caused by stimulated NOCICEPTORS due to tissue injury, inflammation or diseases. It can be divided into somatic or tissue pain and VISCERAL PAIN.
Acute pain that comes on rapidly despite the use of pain medication.
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...