a dose-ranging study of the safety and effectiveness of jnj-42160443 as add-on treatment in patients with osteoarthritis-related pain

Conditions: Osteoarthritis; Osteoarthritis, Hip; Osteoarthritis, Knee; Pain; Arthralgia; Joint Pain

Summary: 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 patients with a diagnosis of osteoarthritis.

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 patients with a diagnosis of osteoarthritis of the hip or the knee who have moderate to severe pain that is not controlled by standard pain medications.osteoarthritis is a chronic disease that affects the joints, and is characterized by degeneration of cartilage and bone. the duration of the study is approximately 133 weeks (3-week screening phase, 12-week double-blind efficacy phase, 92-week double-blind extension phase, and 26-week post treatment phase).jnj-42160443 (10 mg/ml) or matching placebo given as an subcutaneous (injection under the skin) (sc) once every 4 weeks will be administered in the study as 1 of 5 jnj-42160443 dosages:1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks; or 10 mg every 8 weeks, or matching placebo for up to approximately 104 weeks (12-week double-blind efficacy phase + 92-week double-blind extension phase).

Eligibility criteria:
inclusion criteria: diagnosis of osteoarthritis of the hip or the knee; have an average daily pain intensity score of \>=5 averaged over the last 3 days before treatment assignment; receiving a stable dose of non-steroidal anti-inflammatory drugs for a minimum of 5 days each week for the 4 weeks before screening or a stable dose of immediate-release opioids for a minimum of 5 days each week for the 4 weeks before screening, but not exceeding 200 mg oral morphine equivalents per day or a stable dose of long acting opioids for the 4 weeks before screening; but not exceeding 200 mg oral morphine equivalents per day; have a mini mental state examination score of \>=26 at screening. exclusion criteria:history within the past year of any of the following: seizure disorder; intrathecal therapy and ventricular shunts, mild or moderate traumatic brain injury, stroke, transient ischemic attack, meningitis; history of brain injury within the past 15 years consisting of \>= 1 of the following, or with residual sequalae suggesting transient changes in consciousness: brain contusion, intracranial hematoma, either unconsciousness or posttraumatic amnesia lasting more than 24 hours; history of epilepsy or multiple sclerosis; current diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), study joint pain caused by secondary infection, or pain caused by confirmed or suspected neoplasm; any new or unresolved neurologic deficits, including progressive deficits, within 6 months before screening

Keywords: moderate to severe, osteoarthritis-related pain osteoarthritis-related pain moderate to severe chronic pain jnj-42160443