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| 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: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 420 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
001: Experimental
JNJ-42160443 SC injection of 0.1 mL every 4 weeks
|
Drug: JNJ-42160443
SC injection of 0.1 mL every 4 weeks
|
|
002: Experimental
JNJ-42160443 SC injection of 0.3 mL every 4 weeks
|
Drug: JNJ-42160443
SC injection of 0.3 mL every 4 weeks
|
|
003: Experimental
JNJ-42160443 SC injection of 0.3 mL every 8 weeks
|
Drug: JNJ-42160443
SC injection of 0.3 mL every 8 weeks
|
|
004: Experimental
JNJ-42160443 SC injection of 0.6 mL every 8 weeks
|
Drug: JNJ-42160443
SC injection of 0.6 mL every 8 weeks
|
|
005: Experimental
JNJ-42160443 SC injection of 1 mL every 8 weeks
|
Drug: JNJ-42160443
SC injection of 1 mL every 8 weeks
|
|
006: Placebo Comparator
Placebo SC injection of matching placebo
|
Drug: Placebo
SC injection of matching placebo
|
Osteoarthritis is a chronic disease that affects the joints, and is characterized by degeneration of cartilage and bone. Drugs developed for the treatment of osteoarthritis are likely to be given on a daily basis for extended periods of time. Since pain is a common symptom, osteoarthritis pain is widely used as a chronic pain model in pain drug development programs. Nerve growth factor (NGF) plays an important role in the generation of pain in several acute and chronic pain states, and anti-NGF therapy was associated with significant improvement in chronic pain from osteoarthritis. Therefore, anti-NGF therapy may be effective in the treatment of pain from chronic osteoarthritis as well as other chronic pain states. 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 men and women 40 to 80 years of age, inclusive, 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. The study has 4 phases: a screening phase of 3 weeks, a treatment phase of 12 weeks, an extension phase of 92 weeks, and a follow-up phase of 26 weeks after the last dose of study medication. Patients who have an average daily pain intensity score of >=5 averaged over the last 3 days before treatment assignment will receive one of five JNJ-42160443 treatments or placebo given once every 4 or 8 weeks as an injection under the skin while continuing to take their baseline pain medications for 12 weeks. Patients who complete the 12-week treatment phase will be eligible to enter the 92-week extension phase or will discontinue the study. Final visit evaluations will occur 26 weeks after the last dose of study medication is taken, or at early withdrawal from the study. Assessments of effectiveness include daily pain intensity assessments, sleep interference assessment, the Western Ontario and McMaster Osteoarthritis Index 3.1 (WOMAC 3.1), the Brief Pain Inventory (BPI) Short Form, Patient Global Assessment of Change (PGA), Short Form-36 Health Survey (SF-36), Medical Outcomes Study (MOS) Sleep Scale, and Safety, Tolerability, and Efficacy Preview (STEP) interview. Safety assessments include monitoring of adverse events, vital signs, physical examinations, neurologic examinations and evaluations, clinical laboratory evaluations, electrocardiograms (ECGs), the Beck Depression Inventory II (BDI-II), X-ray of joint with pain, and injection site evaluations. The study hypothesis is that JNJ-42160443 is better than placebo as a safe and effective treatment when added to standard pain treatments in patients with moderate to severe, chronic knee or hip pain from osteoarthritis. JNJ-42160443 (10 milligrams in 0.1 milliliter) or matching placebo given as an injection under the skin once every 4 weeks; one of five JNJ-42160443 doses (0.1 mL [1 mg] every 4 weeks; 0.3 mL [3 mg] every 4 weeks; 0.3 mL (3 mg) every 8 weeks; 0.6 mL (6 mg) every 8 weeks; or 1 mL (10 mg) every 8 weeks, or matching placebo.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Show 77 Study Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Responsible Party: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Clinical Leader ) |
| Study ID Numbers: | CR016471, 42160443PAI2004 |
| Study First Received: | September 4, 2009 |
| Last Updated: | January 29, 2010 |
| ClinicalTrials.gov Identifier: | NCT00973141 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Osteoarthritis-related pain Moderate to severe chronic pain JNJ-42160443 |
|
Signs and Symptoms Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Arthritis |
Joint Diseases Pain Rheumatic Diseases Osteoarthritis, Hip Arthralgia |