A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02192190
• Other study ID #: 15515
• Secondary ID: I5Q-MC-CGAF
• Status: Terminated
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 268
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• LY2951742
Administered subcutaneously (SC)

Other:
• Placebo- oral
Administered orally
• Placebo - SC
Administered SC

Drug:
• Celecoxib
Administered orally

Locations

Country	Name	City	State
United States	New Mexico Clinical Research & Osteoporosis Center	Albuquerque	New Mexico
United States	Dream Team Clinical Research	Anaheim	California
United States	The Center for Clinical Trials, Inc.	Biloxi	Mississippi
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Beacon Clinical Research, LLC	Brockton	Massachusetts
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Medex Healthcare Research, Inc.	Chicago	Illinois
United States	Avail Clinical Research LLC	DeLand	Florida
United States	Horizons Clinical Research Center	Denver	Colorado
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	United Osteoporosis Center	Gainesville	Georgia
United States	PharmQuest	Greensboro	North Carolina
United States	PCPMG Clinical Research Unit	Greenville	South Carolina
United States	Drug Trials of America	Hartsdale	New York
United States	AGA Clinical Trials	Hialeah	Florida
United States	Palm Springs Research Institute	Hialeah	Florida
United States	Drug Studies America	Marietta	Georgia
United States	ActivMed Practices & Research, Inc	Methuen	Massachusetts
United States	Community Research Foundation Inc	Miami	Florida
United States	M&M Medical Center	Miami	Florida
United States	Research Institute of South Florida, Inc.	Miami	Florida
United States	Accurate Clinical Research	Nassau Bay	Texas
United States	Medex Healthcare Research, Inc.	New York	New York
United States	Health Research of Hampton Roads Inc	Newport News	Virginia
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	National Clinical Research - Norfolk Inc	Norfolk	Virginia
United States	Renstar Medical Research	Ocala	Florida
United States	Compass Research	Orlando	Florida
United States	Quality Research, Inc.	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Empire Clinical Research	Upland	California
United States	Buynak Clinical Research, P.C.	Valparaiso	Indiana
United States	Arthritis, Rheumatic & Back Disease Associates	Voorhees	New Jersey
United States	Diablo Clinical Research	Walnut Creek	California
United States	Greater Providence Clinical Research, LLC	Warwick	Rhode Island
United States	iM Research	West Covina	California
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	Family Practice Center of Wooster	Wooster	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale	The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC physical function subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of all 17 questions related to physical function. Least Square Mean (LSM) was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.	Baseline, 8 Weeks
Secondary	Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis	The PGA is a patient-rated instrument that measures their assessment of overall OA symptoms. It is based on the participant's response to the question "Considering all the ways your osteoarthritis affects you, how are you doing today?" using a 100 mm VAS (0=very good and 100=very poor). LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.	Baseline, 8 Weeks
Secondary	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)	The responders according to OMERACT-OARSI criteria: participants with at least 50 % improvement in pain or in function scores, along with absolute improvement of 20 mm, were considered responders. Alternatively, participants were considered responders if they showed at least 20% improvement and absolute improvement of 10 mm in at least two of the following scores: pain, function and Patients Global Assessment (PGA) scores.	8 Weeks
Secondary	Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale	The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC stiffness subscale will be calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 2 questions related to stiffness. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.	Baseline, 8 Weeks
Secondary	Change From Baseline to 8 Weeks in the WOMAC Total Score	The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales.The WOMAC total score was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 24 questions. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.	Baseline, 8 Weeks