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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Low Back Pain, Low Back Pain, Recurrent

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 low back pain patients with a diagnosis of chronic low back pain.

Key facts

Study ID

NCT00973024

Run by

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

People needed

389

Starts

2009-09-01

Expected to finish

2011-05-01

Last updated by the study team

2016-06-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic low back pain

You may not qualify if…

• Pain with radiation to the extremity and with neurologic signs
• history within the past year of any of the following: seizure disorder
• intrathecal therapy and ventricular shunts, mild or moderate traumatic brain injury, stroke, or 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), acute spinal cord compression, bowel or bladder dysfunction as a result of cauda equine compression, back 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 — Little Rock, Arkansas, United States
• Study site — Pismo Beach, California, United States
• Study site — San Diego, California, United States
• Study site — Hollywood, Florida, United States
• Study site — Oldsmar, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Woodstock, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Eagle, 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 — Baton Rouge, Louisiana, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Metairie, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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