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

Lilly

Status and phase: Terminated; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: Celecoxib; Other: Placebo - SC; Drug: LY2951742; Other: Placebo- oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT02192190

15515

I5Q-MC-CGAF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 268 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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268 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo capsule orally, once daily for approximately 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks (Treatment period = 16 weeks).

Treatment:

Other: Placebo - SC

Other: Placebo- oral

Celecoxib + Placebo

Active Comparator group

Description:

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).

Treatment:

Other: Placebo - SC

Drug: Celecoxib

LY2951742 5 mg + Placebo

Experimental group

Description:

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).

Treatment:

Other: Placebo - SC

Other: Placebo- oral

Drug: LY2951742

LY2951742 50 mg + Placebo

Experimental group

Description:

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).

Treatment:

Other: Placebo - SC

Other: Placebo- oral

Drug: LY2951742

LY2951742 120 mg + Placebo

Experimental group

Description:

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).

Treatment:

Other: Placebo - SC

Other: Placebo- oral

Drug: LY2951742

LY2951742 300 mg + Placebo

Experimental group

Description:

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).

Treatment:

Other: Placebo - SC

Other: Placebo- oral

Drug: LY2951742