Status:
TERMINATED
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Low Back Pain
Low Back Pain, Recurrent
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 diagn...
Detailed Description
This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the safety and effectiveness of differe...
Eligibility Criteria
Inclusion
- Diagnosis of chronic low back pain
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT00973024
Start Date
September 1 2009
End Date
May 1 2011
Last Update
June 6 2016
Active Locations (60)
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1
Birmingham, Alabama, United States
2
Phoenix, Arizona, United States
3
Tucson, Arizona, United States
4
Little Rock, Arkansas, United States