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A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain

NCT00973141

TerminatedPhase 2

Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

Interventions: JNJ-42160443, JNJ-42160443, JNJ-42160443, Placebo, JNJ-42160443

Countries: United States, Canada, Poland, South Korea

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (77)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Carmichael, California, United States
Fresno, California, United States
Garden Grove, California, United States
Pismo Beach, California, United States
Roseville, California, United States
San Diego, California, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Oldsmar, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Woodstock, Georgia, United States
Boise, Idaho, United States
Meridian, Idaho, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Newburgh, Indiana, United States
Valparaiso, Indiana, United States
West Des Moines, Iowa, United States
Prairie Village, Kansas, United States
Topeka, Kansas, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Lake Charles, Louisiana, United States
Mandeville, Louisiana, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
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