A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
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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 2 |
| 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 |
- 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 ]
- 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: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: JNJ-42160443 1mg every 4 weeks |
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 at a concentration of 10 mg/mL was provided for use in this study).
|
| Experimental: JNJ-42160443 3mg every 4 weeks |
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 at a concentration of 10 mg/mL was provided for use in this study).
|
| Experimental: JNJ-42160443 3mg every 8 weeks |
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 at a concentration of 10 mg/mL was provided for use in this study).
|
| Experimental: JNJ-42160443 6mg every 8 weeks |
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 at a concentration of 10 mg/mL was provided for use in this study).
|
| Experimental: JNJ-42160443 10mg every 8 weeks |
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 at a concentration of 10 mg/mL was provided for use in this study).
|
| Placebo Comparator: Matching placebo every 4 or 8 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 |
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
Hide Study Locations| United States, Alabama | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Phoenix, Arizona, United States | |
| Tucson, Arizona, United States | |
| United States, California | |
| Carmichael, California, United States | |
| Fresno, California, United States | |
| Garden Grove, California, United States | |
| Pismo Beach, California, United States | |
| Roseville, California, United States | |
| San Diego, California, United States | |
| United States, Florida | |
| Clearwater, Florida, United States | |
| Jacksonville, Florida, United States | |
| Oldsmar, Florida, United States | |
| Port Orange, Florida, United States | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| Woodstock, Georgia, United States | |
| United States, Idaho | |
| Boise, Idaho, United States | |
| Meridian, Idaho, United States | |
| United States, Indiana | |
| Evansville, Indiana, United States | |
| Indianapolis, Indiana, United States | |
| Newburgh, Indiana, United States | |
| Valparaiso, Indiana, United States | |
| United States, Iowa | |
| West Des Moines, Iowa, United States | |
| United States, Kansas | |
| Prairie Village, Kansas, United States | |
| Topeka, Kansas, United States | |
| United States, Kentucky | |
| Louisville, Kentucky, United States | |
| United States, Louisiana | |
| Baton Rouge, Louisiana, United States | |
| Lake Charles, Louisiana, United States | |
| Mandeville, Louisiana, United States | |
| Metairie, Louisiana, United States | |
| United States, Maryland | |
| Rockville, Maryland, United States | |
| United States, Massachusetts | |
| Hyannis, Massachusetts, United States | |
| Watertown, Massachusetts, United States | |
| United States, Michigan | |
| East Lansing, Michigan, United States | |
| United States, Nebraska | |
| Omaha, Nebraska, United States | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States | |
| United States, New York | |
| Ny, New York, United States | |
| Williamsville, New York, United States | |
| United States, North Carolina | |
| Greenville, North Carolina, United States | |
| Raleigh, North Carolina, United States | |
| United States, Ohio | |
| Toledo, Ohio, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Duncansville, Pennsylvania, United States | |
| United States, Texas | |
| Austin, Texas, United States | |
| Bedford, Texas, United States | |
| Dallas, Texas, United States | |
| Odessa, Texas, United States | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Draper, Utah, United States | |
| West Jordan, Utah, United States | |
| United States, Virginia | |
| Roanoke, Virginia, United States | |
| United States, Washington | |
| Spokane, Washington, United States | |
| Canada, British Columbia | |
| Burnaby, British Columbia, Canada | |
| Kamloops, British Columbia, Canada | |
| Kelowna, British Columbia, Canada | |
| Penticton, British Columbia, Canada | |
| Canada, Newfoundland and Labrador | |
| St. John'S, Newfoundland and Labrador, Canada | |
| Canada, Ontario | |
| Brampton, Ontario, Canada | |
| Cambridge, Ontario, Canada | |
| London, Ontario, Canada | |
| Mississauga, Ontario, Canada | |
| Newmarket, Ontario, Canada | |
| Sudbury, Ontario, Canada | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Montreal, Quebec, Canada | |
| Sherbrooke, Quebec, Canada | |
| Canada | |
| Quebec, Canada | |
| Korea, Republic of | |
| Busan, Korea, Republic of | |
| Dae-Gu, Korea, Republic of | |
| Daegu, Korea, Republic of | |
| Gwangju, Korea, Republic of | |
| Poland | |
| Bialystok, Poland | |
| Elblag, Poland | |
| Gdynia, Poland | |
| Lublin, Poland | |
| Torun, Poland | |
| Warszawa, Poland | |
| 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: | Johnson & Johnson Pharmaceutical Research & 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: | December 28, 2012 |
| 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 May 23, 2013