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

This study has been terminated.
(Logistic reasons associated with the FDA-imposed clinical hold.)
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00973141
First received: September 4, 2009
Last updated: May 6, 2014
Last verified: May 2014

September 4, 2009
May 6, 2014
September 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00973141 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
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

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Osteoarthritis
  • Osteoarthritis, Hip
  • Osteoarthritis, Knee
  • Pain
  • Arthralgia
  • Joint Pain
  • 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).
  • 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).
  • 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).
  • Drug: Placebo
    Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 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).
  • 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 1mg every 4 weeks
    Intervention: Drug: JNJ-42160443
  • Experimental: JNJ-42160443 3mg every 4 weeks
    Intervention: Drug: JNJ-42160443
  • Experimental: JNJ-42160443 3mg every 8 weeks
    Intervention: Drug: JNJ-42160443
  • Experimental: JNJ-42160443 6mg every 8 weeks
    Intervention: Drug: JNJ-42160443
  • Experimental: JNJ-42160443 10mg every 8 weeks
    Intervention: Drug: JNJ-42160443
  • Placebo Comparator: Matching placebo every 4 or 8 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
467
June 2011
June 2011   (final data collection date for primary outcome measure)

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

Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Poland,   Canada,   Korea, Republic of
 
NCT00973141
CR016471, 42160443PAI2004, 2009-009856-19
Yes
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP