Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Osteoarthritis

H0P-MC-OA01 -

This study is being done to test the safety and efficacy of LY3016859 for the treatment of osteoarthritis pain.

Trial Summary

Age Range
≥40 years
Conditions the trial is for
Osteoarthritis
What the trial is testing?
LY3016859
Could I receive a Placebo?
Yes
Enrollment Goal
117
Trial Dates
Jul 1, 2020 - Aug 26, 2021
How long will I be in the trial?
The study will last about 26 weeks and may include up to 8 visits.
Trial Phase
II

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have a body mass index <40 kilograms per meter squared (kg/m²)

  • Participants must be willing to maintain any non-drug pain relieving therapies (for example, physical therapy) and not start any new non-drug pain-relieving therapies during the study

  • Participants must be willing to stop all pain medications for osteoarthritis, except for rescue medication allowed in the study

  • Participants must have index knee pain for at least 12 weeks

Participants Must Not:

  • Participants must not have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques)

  • Participants must not have surgery planned during the study for any reason

  • Participants must not have had cancer within 2 years, except for certain types of skin cancer (cutaneous basal cell or squamous cell carcinoma) surgically removed

  • Participants must not have an intolerance to acetaminophen or paracetamol

  • Participants must not have an unstable index joint (such as a torn anterior cruciate ligament), surgical hardware or have had a surgical procedure or therapeutic injection in the affected knee within 3 months

  • Participants must not have had an intra-articular injection of hyaluronic acid within 24 weeks

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