Clinical trial NCT00973024: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Low Back Pain
Low Back Pain, Recurrent
Keywords: JNJ-42160443
Low back pain-related pain
moderate to severe, chronic pain
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the average low back pain-related pain intensity score
timeFrame: At the end of the 12-week double-blind efficacy phase
Secondary outcomes:
measure: Change from baseline in the ODI subscale and total scores
timeFrame: At the end of the 12-week double-blind efficacy phase
measure: Change from baseline in the pain severity and pain interference subscales of the BPI Short Form
timeFrame: At the end of the 12-week double-blind efficacy phase
measure: Changes in PGA scores
timeFrame: At the end of the 12-week double-blind efficacy phase
measure: Change from baseline in the pain severity and pain interference subscales of the Brief Pain Inventory (BPI) Short Form
timeFrame: At the end of the 12-week double-blind efficacy phase
measure: Changes in Patient Global Assessment (PGA) scores
timeFrame: At the end of the 12-week double-blind efficacy phase
measure: Change from baseline in the Oswestry Disability Index (ODI) subscale and total scores
timeFrame: At the end of the 12-week double-blind efficacy phase
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Pismo Beach
country: United States
state: California
city: San Diego
country: United States
state: California
city: Hollywood
country: United States
state: Florida
city: Oldsmar
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Eagle
country: United States
state: Idaho
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Valparaiso
country: United States
state: Indiana
city: West Des Moines
country: United States
state: Iowa
city: Prairie Village
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Baton Rouge
country: United States
state: Louisiana
city: Lake Charles
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Watertown
country: United States
state: Massachusetts
city: East Lansing
country: United States
state: Michigan
city: Williamsville
country: United States
state: New York
city: Hickory
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Roanoke
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Renton
country: United States
state: Washington
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Leuven
country: Belgium
city: Kelowna
country: Canada
state: British Columbia
city: Penticton
country: Canada
state: British Columbia
city: St. John'S
country: Canada
state: Newfoundland and Labrador
city: Brampton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Maastricht
country: Netherlands
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.