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Renton |
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State:
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WA |
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| Conditions: |
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Low Back Pain - Low Back Pain, Recurrent |
| Purpose: |
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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.
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| Study summary: |
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Low back pain is a common cause of nonmalignant, chronic pain and represents one of the most
significant socioeconomic health-related problems in developed countries. In 1991, an
estimated annual incidence of 5% was reported in American adults. Up to 50% of working
adults experience back pain every year and 70% of all adults experience it at some time in
their lives. Despite the variety of available medications for nonmalignant, chronic pain,
many patients with chronic pain do not obtain adequate relief or experience unacceptable
side effects from existing medications. Nerve growth factor plays an important role in the
generation of pain in several acute and chronic pain states, and anti-NGF therapy was
associated with significant improvement in chronic pain from osteoarthritis. Therefore,
anti-NGF therapy may be effective in the treatment of pain from chronic osteoarthritis as
well as other chronic pain states.This current study 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 different doses of JNJ-42160443
compared with placebo in the treatment of men and women 18 to 80 years of age, inclusive,
with a diagnosis of chronic low back pain who have moderate to severe, chronic low back pain
that is not controlled by standard pain medications. The study has 4 phases: a screening
phase of 3 weeks, a treatment phase of 12 weeks, an extension phase of 92 weeks, and a
follow-up phase of 26 weeks after the last dose of study medication. Patients who have an
average daily pain intensity score of >=5 averaged over the last 3 days before treatment
assignment will receive one of four JNJ-42160443 treatments or placebo given once every 4
weeks as an injection under the skin while continuing to take their baseline pain
medications for 12 weeks. Patients who complete the 12-week treatment phase will be eligible
to enter the 92-week extension phase or will discontinue the study. Final visit evaluations
will occur 26 weeks after the last dose of study medication is taken, or at early withdrawal
from the study. Assessments of effectiveness include daiy pain intensity assessments, sleep
interference assessment, the Oswestry Disability Index (ODI), the Brief Pain Inventory (BPI)
Short Form, Patient Global Assessment of Change (PGA), Short Form-36 Health Survey (SF-36),
Medical Outcomes Study (MOS) Sleep Scale, the Work Productivity and Impairment
Questionnaire, and Safety, Tolerability, and Efficacy Preview (STEP) interview. Safety
assessments include monitoring of adverse events, vital signs, physical examinations,
neurologic examinations and evaluations, clinical laboratory evaluations, electrocardiograms
(ECGs), the Beck Depression Inventory II (BDI-II), and injection site evaluations. The study
hypothesis is that JNJ-42160443 is better than placebo as a safe and effective treatment
when added to standard pain treatments in patients with moderate to severe, chronic low back
pain. JNJ-42160443 (10 milligrams in 0.1 milliliter) or matching placebo given as an
injection under the skin once every 4 weeks; one of four JNJ-42160443 doses (0.1 mL [1 mg]
every 4 weeks; 0.3 mL [3 mg] every 4 weeks; 0.6 mL (6 mg) loading dose on Day 1 followed by
0.3 mL [3 mg] every 4 weeks; or 1 mL (10 mg) every 4 weeks, or matching placebo. |
| Criteria: |
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Inclusion Criteria:
- Diagnosis of chronic low back pain that must have been present (by history) for at
least >=20 days/month, >=3 hours/day, and >=6 months
- Have low back pain classified by the Quebec Task Force Classification for Spinal
Disorders as either Category 1: pain without radiation to the extremity or Category
2: pain with radiation proximally to the knee and without neurologic signs
- have an average pain intensity score of >=5 averaged over the last 3 days of pain
scores before random assignment (Day 1)
- Must be receiving at least 1 of the following analgesic regimens: stable dose of
non-steroidal anti-inflammatory drugs for a minimum of 5 days each week for the 4
weeks before screening, as 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
- A mini mental state examination score of >=26 at screening
Exclusion Criteria:
- Have low back pain classified by the Quebec Task Force Classification for Spinal
Disorders as Category 3: pain with radiation distally beyond the knee and without
neurologic signs or Category 4: 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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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