A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain
NCT ID: NCT02192190
Last Updated: 2019-09-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
268 participants
INTERVENTIONAL
2014-07-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo capsule orally, once daily for approximately 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
Placebo- oral
Administered orally
Placebo - SC
Administered SC
Celecoxib + Placebo
Celecoxib 200 milligram (mg) capsule orally once daily for approximately 16 weeks. Placebo SC once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
Placebo - SC
Administered SC
Celecoxib
Administered orally
LY2951742 5 mg + Placebo
Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 5 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).
LY2951742
Administered subcutaneously (SC)
Placebo- oral
Administered orally
Placebo - SC
Administered SC
LY2951742 50 mg + Placebo
Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 50 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).
LY2951742
Administered subcutaneously (SC)
Placebo- oral
Administered orally
Placebo - SC
Administered SC
LY2951742 120 mg + Placebo
Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).
LY2951742
Administered subcutaneously (SC)
Placebo- oral
Administered orally
Placebo - SC
Administered SC
LY2951742 300 mg + Placebo
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).
LY2951742
Administered subcutaneously (SC)
Placebo- oral
Administered orally
Placebo - SC
Administered SC
Interventions
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LY2951742
Administered subcutaneously (SC)
Placebo- oral
Administered orally
Placebo - SC
Administered SC
Celecoxib
Administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Dream Team Clinical Research
Anaheim, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Empire Clinical Research
Upland, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
iM Research
West Covina, California, United States
Horizons Clinical Research Center
Denver, Colorado, United States
Avail Clinical Research LLC
DeLand, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
Palm Springs Research Institute
Hialeah, Florida, United States
Community Research Foundation Inc
Miami, Florida, United States
Research Institute of South Florida, Inc.
Miami, Florida, United States
M&M Medical Center
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research
Orlando, Florida, United States
United Osteoporosis Center
Gainesville, Georgia, United States
Drug Studies America
Marietta, Georgia, United States
Medex Healthcare Research, Inc.
Chicago, Illinois, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States
The Center for Clinical Trials, Inc.
Biloxi, Mississippi, United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, United States
Drug Trials of America
Hartsdale, New York, United States
Medex Healthcare Research, Inc.
New York, New York, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
PharmQuest
Greensboro, North Carolina, United States
Family Practice Center of Wooster
Wooster, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Greater Providence Clinical Research, LLC
Warwick, Rhode Island, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
PCPMG Clinical Research Unit
Greenville, South Carolina, United States
Accurate Clinical Research
Nassau Bay, Texas, United States
Quality Research, Inc.
San Antonio, Texas, United States
Health Research of Hampton Roads Inc
Newport News, Virginia, United States
National Clinical Research - Norfolk Inc
Norfolk, Virginia, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Countries
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References
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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.
Other Identifiers
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I5Q-MC-CGAF
Identifier Type: OTHER
Identifier Source: secondary_id
15515
Identifier Type: -
Identifier Source: org_study_id
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