Clinical trial NCT00973141: A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Moderate to Severe Knee or Hip Pain From Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Pain
Arthralgia
Joint Pain
Keywords: Moderate to severe, osteoarthritis-related pain
Osteoarthritis-related pain
Moderate to severe chronic pain
JNJ-42160443
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 467
Sex: ALL
Minimum age (years): 40
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 knee or hip pain in patients with a diagnosis of osteoarthritis.

Detailed description: This current study 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 osteoarthritis of the hip or the knee who have moderate to severe pain that is not controlled by standard pain medications.Osteoarthritis is a chronic disease that affects the joints, and is characterized by degeneration of cartilage and bone. The duration of the study is approximately 133 weeks (3-week screening phase, 12-week double-blind efficacy phase, 92-week double-blind extension phase, and 26-week post treatment phase).JNJ-42160443 (10 mg/mL) or matching placebo given as an subcutaneous (injection under the skin) (SC) once every 4 weeks will be administered in the study as 1 of 5 JNJ-42160443 dosages:1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks; or 10 mg every 8 weeks, or matching placebo for up to approximately 104 weeks (12-week double-blind efficacy phase + 92-week double-blind extension phase).

Eligibility criteria: Inclusion Criteria:

Diagnosis of osteoarthritis of the hip or the knee; Have an average daily pain intensity score of \>=5 averaged over the last 3 days before treatment assignment; Receiving a stable dose of non-steroidal anti-inflammatory drugs for a minimum of 5 days each week for the 4 weeks before screening or a stable dose of immediate-release opioids for a minimum of 5 days each week for the 4 weeks before screening, but not exceeding 200 mg oral morphine equivalents per day or a stable dose of long acting opioids for the 4 weeks before screening; but not exceeding 200 mg oral morphine equivalents per day; Have a mini mental state examination score of \>=26 at screening. Exclusion Criteria:History within the past year of any of the following: seizure disorder; intrathecal therapy and ventricular shunts, mild or moderate traumatic brain injury, stroke, 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), study joint 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 osteoarthritis-related pain intensity score
timeFrame: At the end of the 12-week double-blind efficacy phase
Secondary outcomes:
measure: Change from baseline in average OA-related pain intensity scores
timeFrame: At Weeks 4 and 8 and over the entire double-blind efficacy phase
measure: Change from baseline in Pain, stiffness, and function subscales of the WOMAC 3.1
timeFrame: At the end of the 12-week double-blind efficacy phase
measure: Change from baseline in Pain severity and pain interference subscales of the BPI SF
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
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: Carmichael
country: United States
state: California
city: Fresno
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Diego
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Jacksonville
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: Woodstock
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Meridian
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: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Lake Charles
country: United States
state: Louisiana
city: Mandeville
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Rockville
country: United States
state: Maryland
city: Hyannis
country: United States
state: Massachusetts
city: Watertown
country: United States
state: Massachusetts
city: East Lansing
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Greenville
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: Bedford
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Odessa
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: Spokane
country: United States
state: Washington
city: Burnaby
country: Canada
state: British Columbia
city: Kamloops
country: Canada
state: British Columbia
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: Cambridge
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: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Busan
country: Korea, Republic of
city: Dae-Gu
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gwangju-Si
country: Korea, Republic of
city: Bialystok
country: Poland
city: Elblag
country: Poland
city: Gdynia
country: Poland
city: Lublin
country: Poland
city: Torun
country: Poland
city: Warszawa
country: Poland
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Sanga P, Katz N, Polverejan E, Wang S, Kelly KM, Haeussler J, Thipphawong J. Long-Term Safety and Efficacy of Fulranumab in Patients With Moderate-to-Severe Osteoarthritis Pain: A Phase II Randomized, Double-Blind, Placebo-Controlled Extension Study. Arthritis Rheumatol. 2017 Apr;69(4):763-773. doi: 10.1002/art.39943. Epub 2017 Mar 8.