Clinical trial NCT01094262: A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis
Osteoarthritis, Knee
Pain
Arthralgia
Joint Pain
Keywords: Osteoarthritis pain of the knee
Osteoarthritis
Osteoarthritis, Knee
Pain
Arthralgia
Joint Pain
JNJ-42160443
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 196
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the average daily pain intensity
timeFrame: From Baseline to Week 13 (ie, after 12 weeks of treatment)
Secondary outcomes:
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC 3.1) subscales scores
timeFrame: 12 weeks
measure: Patient Global Assessment (PGA) scale score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Carmichael
country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Hallandale Beach
country: United States
state: Florida
city: Oldsmar
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Perry
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Eagle
country: United States
state: Idaho
city: Avon
country: United States
state: Indiana
city: Evansville
country: United States
state: Indiana
city: Baton Rouge
country: United States
state: Louisiana
city: Mandeville
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Watertown
country: United States
state: Massachusetts
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Mamaroneck
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Greenville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Kettering
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Collegeville
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Grapevine
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: Richardson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Corunna
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.