Study Stopped
Interim assessment: Lack of efficacy
A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain
A Phase 2, Randomized, Double-Blind, Placebo and Active-Controlled Trial of LY2951742 in Patients With Mild to Moderate Osteoarthritis Pain of the Knee
2 other identifiers
interventional
268
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2014
Shorter than P25 for phase_2
38 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
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 14, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
November 8, 2018
CompletedSeptember 10, 2019
August 1, 2019
9 months
July 14, 2014
October 8, 2018
August 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter \[mm\] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.
Baseline, 8 Weeks
Secondary Outcomes (5)
Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale
Baseline, 8 Weeks
Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis
Baseline, 8 Weeks
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)
8 Weeks
Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale
Baseline, 8 Weeks
Change From Baseline to 8 Weeks in the WOMAC Total Score
Baseline, 8 Weeks
Study Arms (6)
Placebo
PLACEBO COMPARATORPlacebo capsule orally, once daily for approximately 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
Celecoxib + Placebo
ACTIVE COMPARATORCelecoxib 200 milligram (mg) capsule orally once daily for approximately 16 weeks. Placebo SC once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
LY2951742 5 mg + Placebo
EXPERIMENTALPlacebo 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 50 mg + Placebo
EXPERIMENTALPlacebo 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 120 mg + Placebo
EXPERIMENTALPlacebo 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 300 mg + Placebo
EXPERIMENTALPlacebo 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).
Interventions
Administered subcutaneously (SC)
Administered orally
Administered SC
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Dream Team Clinical Research
Anaheim, California, 92801, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Empire Clinical Research
Upland, California, 91786, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
iM Research
West Covina, California, 91760, United States
Horizons Clinical Research Center
Denver, Colorado, 80220, United States
Avail Clinical Research LLC
DeLand, Florida, 32720, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Palm Springs Research Institute
Hialeah, Florida, 33012, United States
Community Research Foundation Inc
Miami, Florida, 33155, United States
Research Institute of South Florida, Inc.
Miami, Florida, 33173, United States
M&M Medical Center
Miami, Florida, 33185, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Compass Research
Orlando, Florida, 32806, United States
United Osteoporosis Center
Gainesville, Georgia, 30501, United States
Drug Studies America
Marietta, Georgia, 30060, United States
Medex Healthcare Research, Inc.
Chicago, Illinois, 60602, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, 46383, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, 01844, United States
The Center for Clinical Trials, Inc.
Biloxi, Mississippi, 39531, United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, 08043, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, 87106, United States
Drug Trials of America
Hartsdale, New York, 10530, United States
Medex Healthcare Research, Inc.
New York, New York, 10016, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
Family Practice Center of Wooster
Wooster, Ohio, 44691, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Greater Providence Clinical Research, LLC
Warwick, Rhode Island, 02888, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
PCPMG Clinical Research Unit
Greenville, South Carolina, 29601, United States
Accurate Clinical Research
Nassau Bay, Texas, 77058, United States
Quality Research, Inc.
San Antonio, Texas, 78209, United States
Health Research of Hampton Roads Inc
Newport News, Virginia, 23606, United States
National Clinical Research - Norfolk Inc
Norfolk, Virginia, 23502, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Related Publications (1)
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.
PMID: 30240937DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2014
First Posted
July 16, 2014
Study Start
July 1, 2014
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
September 10, 2019
Results First Posted
November 8, 2018
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.