Study Stopped
Logistic reasons associated with the FDA-imposed clinical hold.
A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthritis
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
3 other identifiers
interventional
196
2 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2010
Shorter than P25 for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2010
CompletedFirst Posted
Study publicly available on registry
March 26, 2010
CompletedStudy Start
First participant enrolled
April 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedMarch 11, 2020
March 1, 2020
1.2 years
March 25, 2010
March 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the average daily pain intensity
From Baseline to Week 13 (ie, after 12 weeks of treatment)
Secondary Outcomes (2)
Western Ontario and McMaster Osteoarthritis Index (WOMAC 3.1) subscales scores
12 weeks
Patient Global Assessment (PGA) scale score
12 weeks
Study Arms (4)
JNJ-42160443 (lower dose)
EXPERIMENTALJNJ-42160443 (higher dose)
EXPERIMENTALOxycodone CR (standard pain medication)
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Carmichael, California, United States
Unknown Facility
Pismo Beach, California, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Hallandale, Florida, United States
Unknown Facility
Oldsmar, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Perry, Georgia, United States
Unknown Facility
Woodstock, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Eagle, Idaho, United States
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Avon, Indiana, United States
Unknown Facility
Evansville, Indiana, United States
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Baton Rouge, Louisiana, United States
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Mandeville, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Watertown, Massachusetts, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Mamaroneck, New York, United States
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Williamsville, New York, United States
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Greenville, North Carolina, United States
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Raleigh, North Carolina, United States
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Kettering, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Collegeville, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Grapevine, Texas, United States
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Lubbock, Texas, United States
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Odessa, Texas, United States
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Richardson, Texas, United States
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San Antonio, Texas, United States
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Corunna, Ontario, Canada
Unknown Facility
Greater Sudbury, Ontario, Canada
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London, Ontario, Canada
Unknown Facility
Newmarket, Ontario, Canada
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Sarnia, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Related Publications (1)
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.
PMID: 27238963DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2010
First Posted
March 26, 2010
Study Start
April 20, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
March 11, 2020
Record last verified: 2020-03