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

Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately Controlled, Moderate to Severe, Chronic Low Back Pain”

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.

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 different doses of JNJ-42160443 compared with placebo in the treatment of patients 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. JNJ-42160443 (10 mg/ml) or matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks); one of four JNJ-42160443 doses (1 mg every 4 wks; 3 mg every 4 wks; 6 mg loading dose on Day 1 followed by 3 mg every 4 wks; or 10 mg every 4 wks, or matching placebo for up to 104 wks (12-wk double-blind efficacy period + 92-wk double-blind extension period).

Intervention(s) in this Clinical Trial

• Drug: JNJ-42160443 3 mg
  • JNJ-42160443: type=exact number, unit=mg/ml, number= 10 mg, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 3 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks
• Drug: JNJ-42160443 1 mg
  • JNJ-42160443: type=exact number, unit=mg/ml, number= 10 mg, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 1 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks
• Drug: JNJ-42160443 6 mg/3mg
  • JNJ-42160443:type=exact number, unit=mg/ml, number=10 mg,form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. 1 inj of 6 mg of JNJ-42160443 on Day 1 followed by 1 inj of 3 mg or matching placebo every 4 wks for up to 104 wks
• Drug: JNJ-42160443 10 mg
  • JNJ-42160443 10 mg: type=exact number, unit=mg/ml, number= 10 mg, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 10 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 001
  • JNJ-42160443 (or matching placebo) SC injection of 0.1 mL every 4 weeks
• Experimental: 002
  • JNJ-42160443 (or matching placebo) SC injection of 0.3 mL every 4 weeks
• Experimental: 003
  • JNJ-42160443 (or matching placebo) SC injection of 0.6 mL on Day 1 followed by 0.3 mL every 4 weeks
• Experimental: 004
  • JNJ-42160443 (or matching placebo) SC injection of 1 mL every 4 weeks

Primary Measures

• Change from baseline in the average low back pain-related pain intensity score
  • Time Frame: At the end of the 12-week double-blind efficacy phase
    Safety Issue?: No

Secondary Measures

• Change from baseline in the ODI subscale and total scores
  • Time Frame: At the end of the 12-week double-blind efficacy phase
    Safety Issue?: No
• Change from baseline in the pain severity and pain interference subscales of the BPI Short Form
  • Time Frame: At the end of the 12-week double-blind efficacy phase
    Safety Issue?: No
• Changes in PGA scores
  • Time Frame: At the end of the 12-week double-blind efficacy phase
    Safety Issue?: No
• Change from baseline in the pain severity and pain interference subscales of the Brief Pain Inventory (BPI) Short Form
  • Time Frame: At the end of the 12-week double-blind efficacy phase
    Safety Issue?: No
• Changes in Patient Global Assessment (PGA) scores
  • Time Frame: At the end of the 12-week double-blind efficacy phase
    Safety Issue?: No
• Change from baseline in the Oswestry Disability Index (ODI) subscale and total scores
  • Time Frame: At the end of the 12-week double-blind efficacy phase
    Safety Issue?: No

Inclusion Criteria:

• Diagnosis of chronic low back pain

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Industry

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00973024

Study ID Number: CR016468

ClinicalTrials.gov Identifier: NCT00973024

Health Authority: United States: Food and Drug Administration