What side effects are associated with this type of intervention?

Common treatments for osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, and various non-pharmacologic interventions. NSAIDs, such as ibuprofen and naproxen, are effective for pain relief but can cause gastrointestinal issues, cardiovascular risks, and renal problems. Glucocorticoids, used for their anti-inflammatory properties, may lead to side effects like weight gain, osteoporosis, and increased blood sugar levels. Non-pharmacologic treatments like acupuncture and lifestyle modifications generally have fewer side effects but may vary in efficacy. Investigational treatments, such as platelet-rich plasma (PRP) and tissue gene therapy, show promise but require further study to fully understand their safety profiles.

What prior FDA approvals exist?

The FDA has approved several NSAIDs for the treatment of osteoarthritis, including ibuprofen, naproxen, meloxicam, and diclofenac, which have shown efficacy in pain relief but come with potential cardiovascular and gastrointestinal risks. Anti-NGF agents like tanezumab and fasinumab have been investigated for osteoarthritis pain management. Tanezumab showed initial promise but was put on hold due to safety concerns, including rapidly progressive osteoarthritis and increased joint replacements. Fasinumab also demonstrated pain reduction but had higher rates of adverse effects, leading to cautious consideration. Other investigational treatments, such as platelet-rich plasma (PRP) and tissue gene therapy, have shown mixed results and are not widely recommended due to inconsistent efficacy and methodological concerns.

What other types of research exist?

Promising novel alternatives for osteoarthritis treatment in 2024 include: 1) Non-pharmacological therapies such as joint distraction and weight loss, which show disease-modifying potential. 2) Biological treatments, including intra-articular injections of agents like sprifermin, which have shown efficacy in reducing cartilage loss and increasing cartilage gain. 3) Emerging therapies under investigation, such as combined biological treatments, nano-molecular approaches, monoclonal antibodies, and personalized target therapies. These options are still in various stages of research and development but hold potential for future OA management.

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Other

Multiple Treatments for Chronic Pain (CPMP Trial)

Phase 2

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study

Have a history of daily pain for at least 12 weeks based on participant report or medical history

Must not have

Have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing different treatments for chronic pain in patients with knee osteoarthritis, chronic low back pain, and diabetic nerve pain. It aims to find effective ways to reduce their chronic pain.

Who is the study for?

This trial is for adults with chronic pain from conditions like osteoarthritis or diabetic neuropathy, who've had daily pain for at least 12 weeks. Participants must be willing to stop all other pain meds except emergency ones, not start new therapies during the study, have a BMI under 40 kg/m², and score specific values on pain scales.

What is being tested?

The study tests multiple interventions (LY3857210 ISA, LY3526318 ISA, etc.) against placebos to manage chronic pain. It's designed to allow each intervention-specific appendix (ISA) to begin independently as they become ready for clinical trials within an overarching protocol.

What are the potential side effects?

Potential side effects are not specified but may include typical drug-related reactions such as nausea, headaches, dizziness or allergic responses. The exact side effects will depend on the individual drugs being tested in each intervention group.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to stop my chronic pain medications except for emergency use during the study.

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I have experienced daily pain for at least 12 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart rhythm problem.

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I've had a procedure in the last 6 months to permanently reduce feeling in a specific area.

Select...

I have been diagnosed with fibromyalgia.

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I am scheduled for surgery during the study, regardless of the reason.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

12Treatment groups

Experimental Treatment

Group I: LY3857210 Osteoarthritis ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3857210 or matching placebo

Group II: LY3857210 Diabetic Neuropathic Pain ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3857210 or matching placebo

Group III: LY3857210 Chronic Back Pain ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3857210 or matching placebo

Group IV: LY3556050 Osteoarthritis ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3556050 or matching placebo

Group V: LY3556050 Diabetic Neuropathic Pain ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3556050 or matching placebo

Group VI: LY3556050 Chronic Back Pain ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3556050 or matching placebo

Group VII: LY3526318 Osteoarthritis ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3526318 or matching placebo

Group VIII: LY3526318 Diabetic Neuropathic Pain ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3526318 or matching placebo

Group IX: LY3526318 Chronic Back Pain ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3526318 or matching placebo

Group X: LY3016859 Osteoarthritis ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3016859 or matching placebo

Group XI: LY3016859 Diabetic Neuropathic Pain ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3016859 or matching placebo

Group XII: LY3016859 Chronic Back Pain ISAExperimental Treatment2 Interventions

Participants are randomized to receive either active LY3016859 or matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo Oral

2014

Completed Phase 3

~200

Placebo

1995

Completed Phase 3

~2670

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, and duloxetine. NSAIDs, such as ibuprofen and naproxen, work by inhibiting cyclooxygenase (COX) enzymes, which reduces the production of prostaglandins that cause inflammation and pain. Glucocorticoids, like prednisone, reduce inflammation by suppressing the immune response and decreasing the production of inflammatory mediators. Duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI), helps manage chronic pain by increasing the levels of neurotransmitters that modulate pain perception. These treatments are crucial for OA patients as they provide symptomatic relief, improve joint function, and enhance the quality of life, even though they do not alter the structural progression of the disease.

Osteoarthritis of the knee - biochemical aspect of applied therapies: a review.Primary care treatment of knee pain--a survey in older adults.Pathophysiology and first-line treatment of osteoarthritis.