Clinical trial NCT02192190: A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain
Official title: A Phase 2, Randomized, Double-Blind, Placebo and Active-Controlled Trial of LY2951742 in Patients With Mild to Moderate Osteoarthritis Pain of the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 268
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain. The study drugs will be given as an injection under the skin and as an oral capsule. The study will last about 28 weeks for each participant.


Eligibility criteria: Inclusion Criteria:

* Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria and confirmed with X-rays and ACR functional class of I to III
* Have been on stable dose of prescription Nonsteroidal Anti-Inflammatory Drugs (NSAIDS), celecoxib, tramadol, or acetaminophen of at least 2000 mg per day for at least 20 days in the past month
* Willing to stop all analgesics for OA pain during the study
* Experienced pain while walking in the target knee of 50-90 mm inclusive on 0-100 Visual Analog Scale (VAS) with an increase in pain while walking of at least 10 mm following washout of current Osteoarthritis pain medications at screening

Exclusion Criteria:

* Allergic to LY2951742, celecoxib, other NSAIDS, including aspirin, and similar drugs
* Arthritis of the knee from other causes
* Uncontrolled hypertension
* Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intra-articular injections, duloxetine, or venlafaxine
* Moderate to severe renal impairment
* Pregnant or lactating

Primary outcomes:
measure: Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
timeFrame: Baseline, 8 Weeks
Secondary outcomes:
measure: Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale
timeFrame: Baseline, 8 Weeks
measure: Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis
timeFrame: Baseline, 8 Weeks
measure: Number of Participants With a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)
timeFrame: 8 Weeks
measure: Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale
timeFrame: Baseline, 8 Weeks
measure: Change From Baseline to 8 Weeks in the WOMAC Total Score
timeFrame: Baseline, 8 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Anaheim
country: United States
facility: Dream Team Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Upland
country: United States
facility: Empire Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: West Covina
country: United States
facility: iM Research
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Miami
country: United States
facility: Community Research Foundation Inc
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida, Inc.
state: Florida
city: Miami
country: United States
facility: M&M Medical Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Gainesville
country: United States
facility: United Osteoporosis Center
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Chicago
country: United States
facility: Medex Healthcare Research, Inc.
state: Illinois
city: Valparaiso
country: United States
facility: Buynak Clinical Research, P.C.
state: Indiana
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc
state: Massachusetts
city: Biloxi
country: United States
facility: The Center for Clinical Trials, Inc.
state: Mississippi
city: Voorhees
country: United States
facility: Arthritis, Rheumatic & Back Disease Associates
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center
state: New Mexico
city: Hartsdale
country: United States
facility: Drug Trials of America
state: New York
city: New York
country: United States
facility: Medex Healthcare Research, Inc.
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Wooster
country: United States
facility: Family Practice Center of Wooster
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Greater Providence Clinical Research, LLC
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: PCPMG Clinical Research Unit
state: South Carolina
city: Nassau Bay
country: United States
facility: Accurate Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads Inc
state: Virginia
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk Inc
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Jin Y, Smith C, Monteith D, Brown R, Camporeale A, McNearney TA, Deeg MA, Raddad E, Xiao N, de la Pena A, Kivitz AJ, Schnitzer TJ. CGRP blockade by galcanezumab was not associated with reductions in signs and symptoms of knee osteoarthritis in a randomized clinical trial. Osteoarthritis Cartilage. 2018 Dec;26(12):1609-1618. doi: 10.1016/j.joca.2018.08.019. Epub 2018 Sep 18.