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

NCT ID: NCT01094262

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-20
• Study Completion Date: 2011-07-01

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.

Conditions

Osteoarthritis; Osteoarthritis, Knee; Pain; Arthralgia; Joint Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

JNJ-42160443 (lower dose)

Group Type: EXPERIMENTAL

JNJ-42160443

Intervention Type: DRUG

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.

JNJ-42160443 (higher dose)

Group Type: EXPERIMENTAL

JNJ-42160443

Intervention Type: DRUG

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.

Oxycodone CR (standard pain medication)

Group Type: ACTIVE_COMPARATOR

Oxycodone CR (standard pain medication)

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

Tucson, Arizona, United States

Carmichael, California, United States

Pismo Beach, California, United States

Clearwater, Florida, United States

Hallandale, Florida, United States

Oldsmar, Florida, United States

St. Petersburg, Florida, United States

Tampa, Florida, United States

Marietta, Georgia, United States

Perry, Georgia, United States

Woodstock, Georgia, United States

Boise, Idaho, United States

Eagle, Idaho, United States

Avon, Indiana, United States

Evansville, Indiana, United States

Baton Rouge, Louisiana, United States

Mandeville, Louisiana, United States

Metairie, Louisiana, United States

New Orleans, Louisiana, United States

Shreveport, Louisiana, United States

Watertown, Massachusetts, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Mamaroneck, New York, United States

Williamsville, New York, United States

Greenville, North Carolina, United States

Raleigh, North Carolina, United States

Kettering, Ohio, United States

Oklahoma City, Oklahoma, United States

Collegeville, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Grapevine, Texas, United States

Lubbock, Texas, United States

Odessa, Texas, United States

Richardson, Texas, United States

San Antonio, Texas, United States

Corunna, Ontario, Canada

Greater Sudbury, Ontario, Canada

London, Ontario, Canada

Newmarket, Ontario, Canada

Sarnia, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Countries

United States; Canada

References

Mayorga AJ, Wang S, Kelly KM, Thipphawong J. Efficacy and safety of fulranumab as monotherapy in patients with moderate to severe, chronic knee pain of primary osteoarthritis: a randomised, placebo- and active-controlled trial. Int J Clin Pract. 2016 Jun;70(6):493-505. doi: 10.1111/ijcp.12807.

Reference Type: DERIVED

PMID: 27238963 (View on PubMed)

Other Identifiers

42160443-PAI2006

Identifier Type: OTHER

Identifier Source: secondary_id

2009-016831-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR017092

Identifier Type: -

Identifier Source: org_study_id