Track topics on Twitter Track topics that are important to you
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 with a diagnosis of chronic low back pain.
Low back pain is a common cause of nonmalignant, chronic pain and represents one of the most significant socioeconomic health-related problems in developed countries. In 1991, an estimated annual incidence of 5% was reported in American adults. Up to 50% of working adults experience back pain every year and 70% of all adults experience it at some time in their lives. Despite the variety of available medications for nonmalignant, chronic pain, many patients with chronic pain do not obtain adequate relief or experience unacceptable side effects from existing medications. Nerve growth factor plays an important role in the generation of pain in several acute and chronic pain states, and anti-NGF therapy was associated with significant improvement in chronic pain from osteoarthritis. Therefore, anti-NGF therapy may be effective in the treatment of pain from chronic osteoarthritis as well as other chronic pain states.This current study is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the safety and effectiveness of different doses of JNJ-42160443 compared with placebo in the treatment of men and women 18 to 80 years of age, inclusive, with a diagnosis of chronic low back pain who have moderate to severe, chronic low back pain that is not controlled by standard pain medications. The study has 4 phases: a screening phase of 3 weeks, a treatment phase of 12 weeks, an extension phase of 92 weeks, and a follow-up phase of 26 weeks after the last dose of study medication. Patients who have an average daily pain intensity score of >=5 averaged over the last 3 days before treatment assignment will receive one of four JNJ-42160443 treatments or placebo given once every 4 weeks as an injection under the skin while continuing to take their baseline pain medications for 12 weeks. Patients who complete the 12-week treatment phase will be eligible to enter the 92-week extension phase or will discontinue the study. Final visit evaluations will occur 26 weeks after the last dose of study medication is taken, or at early withdrawal from the study. Assessments of effectiveness include daiy pain intensity assessments, sleep interference assessment, the Oswestry Disability Index (ODI), the Brief Pain Inventory (BPI) Short Form, Patient Global Assessment of Change (PGA), Short Form-36 Health Survey (SF-36), Medical Outcomes Study (MOS) Sleep Scale, the Work Productivity and Impairment Questionnaire, and Safety, Tolerability, and Efficacy Preview (STEP) interview. Safety assessments include monitoring of adverse events, vital signs, physical examinations, neurologic examinations and evaluations, clinical laboratory evaluations, electrocardiograms (ECGs), the Beck Depression Inventory II (BDI-II), and injection site evaluations. The study hypothesis is that JNJ-42160443 is better than placebo as a safe and effective treatment when added to standard pain treatments in patients with moderate to severe, chronic low back pain. JNJ-42160443 (10 milligrams in 0.1 milliliter) or matching placebo given as an injection under the skin once every 4 weeks; one of four JNJ-42160443 doses (0.1 mL [1 mg] every 4 weeks; 0.3 mL [3 mg] every 4 weeks; 0.6 mL (6 mg) loading dose on Day 1 followed by 0.3 mL [3 mg] every 4 weeks; or 1 mL (10 mg) every 4 weeks, or matching placebo.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment
Low Back Pain
JNJ-42160443, JNJ-42160443, Placebo, JNJ-42160443, JNJ-42160443
Active, not recruiting
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Published on BioPortfolio: 2014-08-27T03:19:30-0400
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 evaluate the safety and effectiveness of JNJ-42160443 in the treatment of moderate to severe neuropathic pain in patients with a diagnosis of diabetic painf...
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...
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 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...
Antidepressants are frequently prescribed as co-analgesics in chronic pain. While their efficacy is well documented for neuropathic pain, the evidence is less clear in musculoskeletal pain conditions....
Although pessimistic beliefs about back pain are associated with low back pain and disability, our understanding of their role in the natural history of the condition is limited. This study examined t...
Assessment of neuropathic pain in chronic low back syndromes is important. However, there is currently no gold standard for its diagnosis. The aim of this observational cross-sectional study was to as...
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...
A condition of persistent pain and discomfort in the BACK and the LEG following lumbar surgery, often seen in patients enrolled in pain centers.
Pain associated with OBSTETRIC LABOR in CHILDBIRTH. It is caused primarily by UTERINE CONTRACTION as well as pressure on the CERVIX; BLADDER; and the GASTROINTESTINAL TRACT. Labor pain mostly occurs in the ABDOMEN; the GROIN; and the BACK.
Acute or chronic pain in the lumbar or sacral regions, which may be associated with musculo-ligamentous SPRAINS AND STRAINS; INTERVERTEBRAL DISK DISPLACEMENT; and other conditions.
Acute or chronic pain located in the posterior regions of the THORAX; LUMBOSACRAL REGION; or the adjacent regions.
Inflammation of the SACROILIAC JOINT. It is characterized by lower back pain, especially upon walking, fever, UVEITIS; PSORIASIS; and decreased range of motion. Many factors are associated with and cause sacroiliitis including infection; injury to spine, lower back, and pelvis; DEGENERATIVE ARTHRITIS; and pregnancy.
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. ...
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...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...