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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Low Back Pain, Low Back Pain, Recurrent

Intervention / Treatment
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* Drug: JNJ-42160443 3 mg
* Drug: JNJ-42160443 1 mg
* Drug: JNJ-42160443 6 mg/3mg
* Drug: JNJ-42160443 10 mg
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-42160443 1 mg<br> | Drug: JNJ-42160443 1 mg<br>* JNJ-42160443: type=exact number, unit=mg, number= 1, 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.<br>Drug: Matching Placebo<br>* Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).<br>|
| Experimental: JNJ-42160443 3 mg<br> | Drug: JNJ-42160443 3 mg<br>* JNJ-42160443: type=exact number, unit=mg, number= 3, 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.<br>Drug: Matching Placebo<br>* Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).<br>|
| Experimental: JNJ-42160443 6 mg/3mg<br> | Drug: JNJ-42160443 6 mg/3mg<br>* JNJ-42160443: type= exact number, unit= mg, number= 3 and 6, 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.<br>Drug: Matching Placebo<br>* Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).<br>|
| Experimental: JNJ-42160443 10 mg<br> | Drug: JNJ-42160443 10 mg<br>* JNJ-42160443 10 mg: type=exact number, unit=mg, number= 10, 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.<br>Drug: Matching Placebo<br>* Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the average low back pain-related pain intensity score |  | At the end of the 12-week double-blind efficacy phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the ODI subscale and total scores |  | At the end of the 12-week double-blind efficacy phase | 
| Change from baseline in the pain severity and pain interference subscales of the BPI Short Form |  | At the end of the 12-week double-blind efficacy phase | 
| Changes in PGA scores |  | At the end of the 12-week double-blind efficacy phase | 
| Change from baseline in the pain severity and pain interference subscales of the Brief Pain Inventory (BPI) Short Form |  | At the end of the 12-week double-blind efficacy phase | 
| Changes in Patient Global Assessment (PGA) scores |  | At the end of the 12-week double-blind efficacy phase | 
| Change from baseline in the Oswestry Disability Index (ODI) subscale and total scores |  | At the end of the 12-week double-blind efficacy phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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JNJ-42160443, Low back pain-related pain, moderate to severe, chronic pain