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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 389
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium
  • Genk, Belgium
  • Leuven, Belgium
• Canada
  • Quebec, Canada
  • British Columbia
    • Kelowna, British Columbia, Canada
    • Penticton, British Columbia, Canada
  • Newfoundland and Labrador
    • St. John'S, Newfoundland and Labrador, Canada
  • Ontario
    • Brampton, Ontario, Canada
    • London, Ontario, Canada
    • Mississauga, Ontario, Canada
    • Newmarket, Ontario, Canada
    • Sarnia, Ontario, Canada
    • Sudbury, Ontario, Canada
    • Toronto, Ontario, Canada
    • Waterloo, Ontario, Canada
  • Quebec
    • Montreal, Quebec, Canada
    • Sherbrooke, Quebec, Canada
    • Trois-Rivieres, Quebec, Canada
• Netherlands
  • Maastricht, Netherlands
• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Arizona
    • Phoenix, Arizona, United States
    • Tucson, Arizona, United States
  • Arkansas
    • Little Rock, Arkansas, United States
  • California
    • Pismo Beach, California, United States
    • San Diego, California, United States
  • Florida
    • Hollywood, Florida, United States
    • Oldsmar, Florida, United States
    • Port Orange, Florida, United States
    • Tampa, Florida, United States
  • Georgia
    • Augusta, Georgia, United States
    • Woodstock, Georgia, United States
  • Idaho
    • Boise, Idaho, United States
    • Eagle, Idaho, United States
  • Indiana
    • Evansville, Indiana, United States
    • Indianapolis, Indiana, United States
    • Newburgh, Indiana, United States
    • Valparaiso, Indiana, United States
  • Iowa
    • West Des Moines, Iowa, United States
  • Kansas
    • Prairie Village, Kansas, United States
    • Topeka, Kansas, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
    • Lake Charles, Louisiana, United States
    • Metairie, Louisiana, United States
    • New Orleans, Louisiana, United States
  • Massachusetts
    • Watertown, Massachusetts, United States
  • Michigan
    • East Lansing, Michigan, United States
  • New York
    • Williamsville, New York, United States
  • North Carolina
    • Hickory, North Carolina, United States
    • Raleigh, North Carolina, United States
  • Ohio
    • Toledo, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States
  • Texas
    • Austin, Texas, United States
    • Dallas, Texas, United States
    • San Antonio, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
    • West Jordan, Utah, United States
  • Virginia
    • Roanoke, Virginia, United States
    • Virginia Beach, Virginia, United States
  • Washington
    • Renton, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Investigators: Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

General Publications

• Sanga P, Polverejan E, Wang S, Kelly KM, Thipphawong J. Efficacy, Safety, and Tolerability of Fulranumab as an Adjunctive Therapy in Patients With Inadequately Controlled, Moderate-to-Severe Chronic Low Back Pain: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Dose-loading Phase II Study. Clin Ther. 2016 Jun;38(6):1435-1450. doi: 10.1016/j.clinthera.2016.03.030. Epub 2016 Apr 18.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: September 4, 2009
• First Submitted That Met QC Criteria: September 4, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: JNJ-42160443; Low back pain-related pain; moderate to severe, chronic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CR016468; 42160443PAI2003 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.); 2009-009857-17 (EudraCT Number)