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| ID | Type | Description | Link |
|---|---|---|---|
| 42160443-PAI2006 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | |
| 2009-016831-36 | EudraCT Number |
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Logistic reasons associated with the FDA-imposed clinical hold.
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The purpose of this study is to evaluate pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo.
This is a double-blind (neither the physician nor the patient knows the name of the assigned drug) study evaluating pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo. The study will last for about 42 weeks. Patients will receive treatment for 16 weeks. Patients who qualify for the study based on their level of pain as well as other factors will receive one of the 4 possible treatments as determined by chance. Before entering the study, patients must stop using their present pain medication. During the study, patients will answer questions about their pain, side effects, and have tests performed to monitor their physical condition. The main purpose of the study is to compare pain relief with JNJ-42160443 to that of a standard pain treatment or placebo. After the treatment period, patients can return to taking the pain medication that they used before the start of the study, and their physical condition will continue to be monitored. JNJ 42160443 10 mg/mL will be provided for use in the study. Patients will receive 1 of 4 treatments for 16 weeks (wks): lower dosage of JNJ 42160443 by subcutaneous (under the skin) (SC) injection once every 4 wks + Placebo (P) capsule orally (by mouth) (PO) 2x/day, higher dosage of JNJ 42160443 by SC injection once every 4 wks + P capsule PO 2x/day, standard pain medication capsule PO 2x/day + P by SC injection once every 4 wks, or P capsule PO 2x/day + P by SC injection once every 4 wks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-42160443 (lower dose) | Experimental |
| |
| JNJ-42160443 (higher dose) | Experimental |
| |
| Oxycodone CR (standard pain medication) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone CR (standard pain medication) | Drug | Oxycodone CR: Type=exact number, unit=mg, number= 10-50, form=capsule, route=oral use and Placebo: Form=solution for injection, route=Subcutaneous use. Oxycodone CR capsule twice a day for 16 weeks and one placebo injection every 4 weeks for 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the average daily pain intensity | From Baseline to Week 13 (ie, after 12 weeks of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Osteoarthritis Index (WOMAC 3.1) subscales scores | The WOMAC 3.1 is a multi-dimensional, osteoarthritis specific questionnaire designed to assess clinically important symptoms of the hip and/or knee. | 12 weeks |
| Patient Global Assessment (PGA) scale score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27238963 | Derived | Mayorga AJ, Wang S, Kelly KM, Thipphawong J. Efficacy and safety of fulranumab as monotherapy in patients with moderate to severe, chronic knee pain of primary osteoarthritis: a randomised, placebo- and active-controlled trial. Int J Clin Pract. 2016 Jun;70(6):493-505. doi: 10.1111/ijcp.12807. |
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| JNJ-42160443 | Drug | JNJ-42160443: Type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks. |
|
| JNJ-42160443 | Drug | JNJ-42160443: Type=exact number, unit=mg, number= 9, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks. |
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| Placebo | Drug | Form=solution for injection, route=Subcutaneous use and Form=capsule, route=Oral use. One placebo injection every 4 weeks and a placebo capsule twice a day for 16 weeks. |
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The PGA is a single item that the patient completes to indicate their perception of their osteoarthritis status, on an 11-point numerical rating scale from 0 (Very Good) to 10 (Very Bad). |
| 12 weeks |
| Carmichael |
| California |
| United States |
| Pismo Beach | California | United States |
| Clearwater | Florida | United States |
| Hallandale | Florida | United States |
| Oldsmar | Florida | United States |
| St. Petersburg | Florida | United States |
| Tampa | Florida | United States |
| Marietta | Georgia | United States |
| Perry | Georgia | United States |
| Woodstock | Georgia | United States |
| Boise | Idaho | United States |
| Eagle | Idaho | United States |
| Avon | Indiana | United States |
| Evansville | Indiana | United States |
| Baton Rouge | Louisiana | United States |
| Mandeville | Louisiana | United States |
| Metairie | Louisiana | United States |
| New Orleans | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Watertown | Massachusetts | United States |
| St Louis | Missouri | United States |
| Omaha | Nebraska | United States |
| Mamaroneck | New York | United States |
| Williamsville | New York | United States |
| Greenville | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Kettering | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Collegeville | Pennsylvania | United States |
| Duncansville | Pennsylvania | United States |
| Grapevine | Texas | United States |
| Lubbock | Texas | United States |
| Odessa | Texas | United States |
| Richardson | Texas | United States |
| San Antonio | Texas | United States |
| Corunna | Ontario | Canada |
| Greater Sudbury | Ontario | Canada |
| London | Ontario | Canada |
| Newmarket | Ontario | Canada |
| Sarnia | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000592179 | fulranumab |
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