A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthritis

Stopped early · Phase 2 · Has a placebo group

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

In brief

The purpose of this study is to evaluate 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.

Key facts

Study ID

NCT01094262

Run by

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

People needed

196

Starts

2010-04-20

Expected to finish

2011-07-01

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…

• Clinical diagnosis of osteoarthritis of the knee
• Have moderate to severe pain based on a trial questionnaire
• Must be on a stable dose of pain medication for 4 weeks before entering the trial
• Medically stable condition

You may not qualify if…

• History of joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial
• Diabetes mellitus
• Uncontrolled cardiovascular disease or hypertension
• Previous treatment with another investigational NGF inhibitor therapy

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Carmichael, California, United States
• Study site — Pismo Beach, California, United States
• Study site — Clearwater, Florida, United States
• Study site — Hallandale, Florida, United States
• Study site — Oldsmar, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Perry, Georgia, United States
• Study site — Woodstock, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Eagle, Idaho, United States
• Study site — Avon, Indiana, United States
• Study site — Evansville, Indiana, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Mandeville, Louisiana, United States
• Study site — Metairie, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Watertown, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Mamaroneck, New York, United States
• Study site — Williamsville, New York, United States

Full record on ClinicalTrials.gov

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