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

Phase 2

Terminated

• Conditions: Pain; Osteoarthritis; Osteoarthritis, Knee; Arthralgia; Joint Pain
• Interventions: Drug: JNJ-42160443; Drug: Placebo; Drug: Oxycodone CR (standard pain medication)

• Registration Number: NCT01094262
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

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.

Detailed Description

This is a double-blind (neither the physician nor the patient knows the name of the assigned drug) study evaluating 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. The study will last for about 42 weeks. Patients will receive treatment for 16 weeks. Patients who qualify for the study based on their level of pain as well as other factors will receive one of the 4 possible treatments as determined by chance. Before entering the study, patients must stop using their present pain medication. During the study, patients will answer questions about their pain, side effects, and have tests performed to monitor their physical condition. The main purpose of the study is to compare pain relief with JNJ-42160443 to that of a standard pain treatment or placebo. After the treatment period, patients can return to taking the pain medication that they used before the start of the study, and their physical condition will continue to be monitored. JNJ 42160443 10 mg/mL will be provided for use in the study. Patients will receive 1 of 4 treatments for 16 weeks (wks): lower dosage of JNJ 42160443 by subcutaneous (under the skin) (SC) injection once every 4 wks + Placebo (P) capsule orally (by mouth) (PO) 2x/day, higher dosage of JNJ 42160443 by SC injection once every 4 wks + P capsule PO 2x/day, standard pain medication capsule PO 2x/day + P by SC injection once every 4 wks, or P capsule PO 2x/day + P by SC injection once every 4 wks.

Study Timeline

• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Study Start: 2010-04-20
• Primary Completion: 2011-07-01
• Study Completion: 2011-07-01
• Disposition First Submitted: 2012-04-26
• Disposition First Submitted QC: 2012-04-26
• Disposition First Posted: 2012-04-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JNJ-42160443 (lower dose)	JNJ-42160443	-
JNJ-42160443 (higher dose)	JNJ-42160443	-
Placebo	Placebo	-
Oxycodone CR (standard pain medication)	Oxycodone CR (standard pain medication)	-

Primary Outcome Measures

Name	Time	Method
Change in the average daily pain intensity	From Baseline to Week 13 (ie, after 12 weeks of treatment)

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Osteoarthritis Index (WOMAC 3.1) subscales scores	12 weeks	The WOMAC 3.1 is a multi-dimensional, osteoarthritis specific questionnaire designed to assess clinically important symptoms of the hip and/or knee.
Patient Global Assessment (PGA) scale score	12 weeks	The PGA is a single item that the patient completes to indicate their perception of their osteoarthritis status, on an 11-point numerical rating scale from 0 (Very Good) to 10 (Very Bad).