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

2014-08-27 03:19:30 | BioPortfolio

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 diagnosis of chronic low back pain.

Description

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment

Conditions

Low Back Pain

Intervention

JNJ-42160443, JNJ-42160443, Placebo, JNJ-42160443, JNJ-42160443

Status

Active, not recruiting

Source

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

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:30-0400

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