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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 to a standard pain treatment and placebo.
The study will last for about 42 weeks. Patients will receive treatment for 16 weeks. Patients who qualify for the study based on their level of pain as well as other factors will receive one of the 4 possible treatments as determined by chance. Before entering the study, subjects must stop using their present pain medication. During the study Patients will answer questions about their pain, side effects, and have tests performed to monitor their physical condition. The main purpose of the study is to compare pain relief with JNJ-42160443 to that of a standard pain treatment or placebo. All patients will receive an injection (JNJ-42160443 study drug or placebo) once every 4 weeks. All patients will also take a capsule (standard pain treatment or placebo) 2 times every day. After the treatment period, patients can return to taking the pain medication that they used before the start of the study, and their physical condition will continue to be monitored. Patients will receive one of these 4 possible treatments for 16 weeks. Lower Dosage of JNJ 42160443 (injection once every 4 weeks) + Placebo (capsule taken by mouth 2 times a day) ; Higher Dosage of JNJ 42160443 (injection once every 4 weeks) + Placebo (capsule taken by mouth 2 times a day); Standard pain medication (capsule taken by mouth 2 times a day ) + Placebo (injection once every 4 weeks); Placebo (capsule taken by mouth 2 times a day) + placebo (injection once every 4 weeks)
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
JNJ-42160443, placebo, JNJ-42160443, standard pain medication
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Published on BioPortfolio: 2014-08-27T03:14:58-0400
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