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

March 6, 2020 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
    • Ontario
      • Corunna, Ontario, Canada
      • London, Ontario, Canada
      • Newmarket, Ontario, Canada
      • Sarnia, Ontario, Canada
      • Sudbury, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Carmichael, California, United States
      • Pismo Beach, California, United States
    • Florida
      • Clearwater, Florida, United States
      • Hallandale Beach, Florida, United States
      • Oldsmar, Florida, United States
      • Saint Petersburg, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
      • Perry, Georgia, United States
      • Woodstock, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
      • Eagle, Idaho, United States
    • Indiana
      • Avon, Indiana, United States
      • Evansville, Indiana, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Mandeville, Louisiana, United States
      • Metairie, Louisiana, United States
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Watertown, Massachusetts, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Mamaroneck, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Greenville, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Kettering, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Collegeville, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
    • Texas
      • Grapevine, Texas, United States
      • Lubbock, Texas, United States
      • Odessa, Texas, United States
      • Richardson, Texas, United States
      • San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Form=solution for injection, route=Subcutaneous use and Form=capsule, route=Oral use. One placebo injection every 4 weeks and a placebo capsule twice a day for 16 weeks.
Experimental: JNJ-42160443 (lower dose)
Drug: JNJ-42160443
JNJ-42160443: Type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks.
Drug: JNJ-42160443
JNJ-42160443: Type=exact number, unit=mg, number= 9, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks.
Experimental: JNJ-42160443 (higher dose)
Drug: JNJ-42160443
JNJ-42160443: Type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks.
Drug: JNJ-42160443
JNJ-42160443: Type=exact number, unit=mg, number= 9, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks.
Active Comparator: Oxycodone CR (standard pain medication)
Drug: Oxycodone CR (standard pain medication)
Oxycodone CR: Type=exact number, unit=mg, number= 10-50, form=capsule, route=oral use and Placebo: Form=solution for injection, route=Subcutaneous use. Oxycodone CR capsule twice a day for 16 weeks and one placebo injection every 4 weeks for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the average daily pain intensity
Time Frame: From Baseline to Week 13 (ie, after 12 weeks of treatment)
From Baseline to Week 13 (ie, after 12 weeks of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Osteoarthritis Index (WOMAC 3.1) subscales scores
Time Frame: 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.
12 weeks
Patient Global Assessment (PGA) scale score
Time Frame: 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).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 25, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017092
  • 42160443-PAI2006 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
  • 2009-016831-36 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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