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A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
This study is currently recruiting participants.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., January 2010
First Received: September 4, 2009   Last Updated: January 29, 2010   History of Changes
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

Resource links provided by NLM:


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 ]

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

Detailed Description:

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
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

Contacts
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
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

Additional Information:
No publications provided

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

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Osteoarthritis-related pain
Moderate to severe chronic pain
JNJ-42160443

Additional relevant MeSH terms:
Signs and Symptoms
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Arthritis
Joint Diseases
Pain
Rheumatic Diseases
Osteoarthritis, Hip
Arthralgia

ClinicalTrials.gov processed this record on February 08, 2010