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

This study has been terminated.
(Interim assessment: Lack of efficacy)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02192190
First received: July 14, 2014
Last updated: September 3, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Osteoarthritis, Knee
Drug: LY2951742
Other: Placebo - Oral
Other: Placebo - SC
Drug: Celecoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale [ Time Frame: Baseline, 8 Weeks ]

Secondary Outcome Measures:
  • Change from Baseline to 8 Weeks in the WOMAC Physical Function Subscale [ Time Frame: Baseline, 8 Weeks ]
  • Change in Baseline to 8 Weeks in Participant's Global Assessment of Osteoarthritis [ Time Frame: Baseline, 8 Weeks ]
  • Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trial Response Criteria Initiative (OMERACT-OARSI) [ Time Frame: 8 Weeks ]
  • Change from Baseline to 8 Weeks in the WOMAC Stiffness Subscale [ Time Frame: Baseline, 8 Weeks ]
  • Change from Baseline to 8 Weeks in the WOMAC Total Score [ Time Frame: Baseline, 8 Weeks ]

Enrollment: 268
Study Start Date: July 2014
Study Completion Date: June 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 LY2951742 + Placebo
Placebo capsule orally, once daily for approximately 16 weeks. Subcutaneous (SC) injections of dose 1 LY2951742 once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
Drug: LY2951742
Administered SC
Other: Placebo - Oral
Administered orally
Experimental: Dose 2 LY2951742 + Placebo
Placebo capsule orally, once daily for approximately 16 weeks. SC injections of dose 2 LY2951742 once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
Drug: LY2951742
Administered SC
Other: Placebo - Oral
Administered orally
Experimental: Dose 3 LY2951742 + Placebo
Placebo capsule orally, once daily for approximately 16 weeks. SC injections of dose 3 LY2951742 once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
Drug: LY2951742
Administered SC
Other: Placebo - Oral
Administered orally
Experimental: Dose 4 LY2951742 + Placebo
Placebo capsule orally, once daily for approximately 16 weeks. SC injections of dose 4 LY2951742 once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
Drug: LY2951742
Administered SC
Other: Placebo - Oral
Administered orally
Placebo Comparator: Placebo
Placebo capsule orally, once daily for approximately 16 weeks. Placebo SC once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
Other: Placebo - Oral
Administered orally
Other: Placebo - SC
Administered SC
Active Comparator: 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).
Other: Placebo - SC
Administered SC
Drug: Celecoxib
Administered orally

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 in the target knee as based on the Visual Analog Scale (VAS)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02192190

  Show 38 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02192190     History of Changes
Other Study ID Numbers: 15515
I5Q-MC-CGAF ( Other Identifier: Eli Lilly and Company )
Study First Received: July 14, 2014
Last Updated: September 3, 2015

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on March 28, 2017