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

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ClinicalTrials.gov Identifier: NCT02192190
Recruitment Status : Terminated (Interim assessment: Lack of efficacy)
First Posted : July 16, 2014
Last Update Posted : September 18, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2014
Primary Completion Date : April 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Change from Baseline to 8 Weeks in the WOMAC Physical Function Subscale [ Time Frame: Baseline, 8 Weeks ]
  2. Change in Baseline to 8 Weeks in Participant's Global Assessment of Osteoarthritis [ Time Frame: Baseline, 8 Weeks ]
  3. 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 ]
  4. Change from Baseline to 8 Weeks in the WOMAC Stiffness Subscale [ Time Frame: Baseline, 8 Weeks ]
  5. Change from Baseline to 8 Weeks in the WOMAC Total Score [ Time Frame: Baseline, 8 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 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