A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthritis

TerminatedPhase 2NCT01094262

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 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.

Study details

Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-42160443 as Monotherapy in Subjects With Moderate to Severe, Chronic Knee Pain From Osteoarthritis
Conditions: Osteoarthritis
Osteoarthritis, Knee
Pain
Arthralgia
Joint Pain
Interventions: Drug: Oxycodone CR (standard pain medication)
Drug: JNJ-42160443
Drug: JNJ-42160443
Drug: Placebo
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2010-04-20
Primary completion: 2011-07-01
Sex: All
Age range: from 40 Years to 80 Years
Results posted: No results posted in this snapshot
Countries: Canada, United States
Total sites listed: 44

Eligibility criteria

Show eligibility criteria (verbatim from the registry)

Inclusion Criteria: * Clinical diagnosis of osteoarthritis of the knee * Have moderate to severe pain based on a trial questionnaire * Must be on a stable dose of pain medication for 4 weeks before entering the trial * Medically stable condition Exclusion Criteria: * History of joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial * Diabetes mellitus * Uncontrolled cardiovascular disease or hypertension * Previous treatment with another investigational NGF inhibitor therapy

Canadian sites (8)

Facility	City	Province
	Corunna	Ontario
	Greater Sudbury	Ontario
	London	Ontario
	Newmarket	Ontario
	Sarnia	Ontario
	Toronto	Ontario
	Montreal	Quebec
	Québec	Quebec

Canadian sites for NCT01094262. 8 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01094262