A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
TerminatedPhase 2NCT00973141
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
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.
Study details
- 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
- Interventions
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Start date
- 2009-09-16
- Primary completion
- 2011-06-30
- Sex
- All
- Age range
- from 40 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada, Poland, South Korea, United States
- Total sites listed
- 77
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Canadian sites (16)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00973141