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

Phase 2

Terminated

• Conditions: Low Back Pain; Low Back Pain, Recurrent
• Interventions: Drug: JNJ-42160443 1 mg; Drug: JNJ-42160443 10 mg; Drug: JNJ-42160443 3 mg; Drug: JNJ-42160443 6 mg/3mg; Drug: Matching Placebo

• Registration Number: NCT00973024
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief 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.

Detailed Description

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).

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-04
• Study First Submitted QC: 2009-09-04
• Study First Posted: 2009-09-09
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Disposition First Submitted: 2012-04-26
• Disposition First Submitted QC: 2012-04-26
• Disposition First Posted: 2012-04-30
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 389

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JNJ-42160443 1 mg	JNJ-42160443 1 mg	-
JNJ-42160443 1 mg	Matching Placebo	-
JNJ-42160443 6 mg/3mg	Matching Placebo	-
JNJ-42160443 10 mg	JNJ-42160443 10 mg	-
JNJ-42160443 3 mg	JNJ-42160443 3 mg	-
JNJ-42160443 3 mg	Matching Placebo	-
JNJ-42160443 6 mg/3mg	JNJ-42160443 6 mg/3mg	-
JNJ-42160443 10 mg	Matching Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change from baseline in the ODI subscale and total scores	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
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
Change from baseline in the Oswestry Disability Index (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