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

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00973141

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Pain Arthralgia Joint Pain	Drug: JNJ-42160443 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Change from baseline in the average osteoarthritis-related pain intensity score [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in average OA-related pain intensity scores [ Time Frame: At Weeks 4 and 8 and over the entire double-blind efficacy phase ] [ Designated as safety issue: No ]
Change from baseline in Pain, stiffness, and function subscales of the WOMAC 3.1 [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]
Change from baseline in Pain severity and pain interference subscales of the BPI SF [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]
Changes in PGA scores [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]

Enrollment:	467
Study Start Date:	September 2009
Study Completion Date:	June 2011
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 Type=exact number, unit=mg, number=1, form=solution for injection, route=Subcutaneous use. One injection of 1 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 10 mg/mL provided for use in the study).	Drug: JNJ-42160443 Type=exact number, unit=mg, number=1, form=solution for injection, route=Subcutaneous use. One injection of 1 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 10 mg/mL provided for use in the study).
Experimental: 002 Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 10 mg/mL provided for use in the study).	Drug: JNJ-42160443 Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 10 mg/mL provided for use in the study).
Experimental: 003 Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 10 mg/mL provided for use in the study).	Drug: JNJ-42160443 Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 10 mg/mL provided for use in the study).
Experimental: 004 Type=exact number, unit=mg, number=6, form=solution for injection, route=Subcutaneous use. One injection of 6 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 10 mg/mL provided for use in the study).	Drug: JNJ-42160443 Type=exact number, unit=mg, number=6, form=solution for injection, route=Subcutaneous use. One injection of 6 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 10 mg/mL provided for use in the study).
Experimental: 005 Type=exact number, unit=mg, number=10, form=solution for injection, route=Subcutaneous use. One injection of 10 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ 42160443 10 mg/mL provided for use in the study).	Drug: JNJ-42160443 Type=exact number, unit=mg, number=10, form=solution for injection, route=Subcutaneous use. One injection of 10 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ 42160443 10 mg/mL provided for use in the study).
Placebo Comparator: 006 Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 weeks	Drug: Placebo Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 weeks.

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

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973141

Show 78 Study Locations

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

No publications provided

Responsible Party:	Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00973141 History of Changes
Other Study ID Numbers:	CR016471, 42160443PAI2004, 2009-009856-19
Study First Received:	September 4, 2009
Last Updated:	August 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Moderate to severe, osteoarthritis-related pain
Osteoarthritis-related pain
Moderate to severe chronic pain
JNJ-42160443

Additional relevant MeSH terms:

Arthralgia
Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Joint Diseases

Musculoskeletal Diseases
Pain
Signs and Symptoms
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012