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View Clinical Trial (Medical Research Study)
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A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain - NCT00973141- (Clinical Trial 351741)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy351741.aspx
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| City: |
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Spokane |
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State:
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WA |
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| Conditions: |
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Osteoarthritis - Osteoarthritis, Hip - Osteoarthritis, Knee - Pain - Arthralgia - Joint Pain |
| 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 knee or hip pain
in patients with a diagnosis of osteoarthritis.
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| Study summary: |
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Osteoarthritis is a chronic disease that affects the joints, and is characterized by
degeneration of cartilage and bone. Drugs developed for the treatment of osteoarthritis are
likely to be given on a daily basis for extended periods of time. Since pain is a common
symptom, osteoarthritis pain is widely used as a chronic pain model in pain drug development
programs. Nerve growth factor (NGF) 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 40 to 80 years of age, inclusive, with a diagnosis
of osteoarthritis of the hip or the knee who have moderate to severe 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 five JNJ-42160443 treatments or placebo given once every 4 or 8 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 daily pain intensity assessments, sleep
interference assessment, the Western Ontario and McMaster Osteoarthritis Index 3.1 (WOMAC
3.1), 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, 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), X-ray of joint with pain, 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 knee or
hip pain from osteoarthritis. JNJ-42160443 (10 milligrams in 0.1 milliliter) or matching
placebo given as an injection under the skin once every 4 weeks; one of five JNJ-42160443
doses (0.1 mL [1 mg] every 4 weeks; 0.3 mL [3 mg] every 4 weeks; 0.3 mL (3 mg) every 8
weeks; 0.6 mL (6 mg) every 8 weeks; or 1 mL (10 mg) every 8 weeks, or matching placebo. |
| Criteria: |
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Inclusion Criteria:
- 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 sequelae 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 |
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| Study is available at: |
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Spokane, WA
United States
Primary Contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email: info1@veritasmedicine.com |
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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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November 17, 2009 |
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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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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