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

Stopped early · Phase 2 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT00973141

Run by

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

People needed

467

Starts

2009-09-16

Expected to finish

2011-06-30

Last updated by the study team

2020-03-11

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Carmichael, California, United States
• Study site — Fresno, California, United States
• Study site — Garden Grove, California, United States
• Study site — Pismo Beach, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — Clearwater, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Oldsmar, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Woodstock, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Evansville, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Newburgh, Indiana, United States
• Study site — Valparaiso, Indiana, United States
• Study site — West Des Moines, Iowa, United States
• Study site — Prairie Village, Kansas, United States
• Study site — Topeka, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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