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

Phase 2

Terminated

• Conditions: Osteoarthritis; Osteoarthritis, Hip; Pain; Osteoarthritis, Knee; Arthralgia; Joint Pain
• Interventions: Drug: JNJ-42160443; Drug: Placebo

• Registration Number: NCT00973141
• 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 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).

Study Timeline

• Study First Submitted: 2009-09-04
• Study First Submitted QC: 2009-09-04
• Study First Posted: 2009-09-09
• Study Start: 2009-09-16
• Primary Completion: 2011-06-30
• Study Completion: 2011-06-30
• Disposition First Submitted: 2011-07-08
• Disposition First Submitted QC: 2011-07-08
• Disposition First Posted: 2011-07-14
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 467

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JNJ-42160443 1mg every 4 weeks	JNJ-42160443	-
JNJ-42160443 3mg every 4 weeks	JNJ-42160443	-
JNJ-42160443 6mg every 8 weeks	JNJ-42160443	-
JNJ-42160443 10mg every 8 weeks	JNJ-42160443	-
Matching placebo every 4 or 8 weeks	Placebo	-
JNJ-42160443 3mg every 8 weeks	JNJ-42160443	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the average osteoarthritis-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 Pain, stiffness, and function subscales of the WOMAC 3.1	At the end of the 12-week double-blind efficacy phase
Change from baseline in Pain severity and pain interference subscales of the BPI SF	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 average OA-related pain intensity scores	At Weeks 4 and 8 and over the entire double-blind efficacy phase