What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, particularly injectable formulations like glucocorticoid injections, can have several side effects. Glucocorticoid injections may cause local pain, infection, and potential systemic effects such as elevated blood sugar levels. NSAIDs, often used for pain relief, carry risks of gastrointestinal issues, cardiovascular problems, and kidney damage. Platelet-rich plasma (PRP) injections, another treatment option, generally have minor and transient side effects like pain, bleeding, tenderness, and swelling at the injection site, but also carry a risk of local infection. These side effects should be discussed with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, including nonsteroidal anti-inflammatory drugs (NSAIDs) and intra-articular injections such as glucocorticoids and hyaluronic acid. Injectable formulations like hyaluronic acid are used to provide lubrication and reduce pain in the knee joint. Investigational treatments, such as platelet-rich plasma and anti-nerve growth factor (anti-NGF) agents like tanezumab, have shown promise but also raised safety concerns. The trial for SL-1002, an injectable formulation for knee pain, is part of ongoing efforts to find effective and safe treatments for osteoarthritis.

What other types of research exist?

Promising, novel alternatives to SL-1002 for reducing knee pain associated with osteoarthritis include: 1) Ketoprofen in Transfersome® gel (IDEA-033), which has shown efficacy in reducing pain in a 12-week study. 2) Non-animal stabilized hyaluronic acid (NASHA), which demonstrated efficacy in a 26-week study with a single intra-articular injection. 3) Cross-linked hyaluronate (Gel-200), which has been shown to be safe and effective in a 13-week pivotal trial with the option for retreatment. 4) Diclofenac etalhyaluronate (DF-HA), which showed positive results in a 24-week study with intra-articular injections at weeks 0, 4, and 8. 5) Tanezumab, which demonstrated significant pain reduction in a 32-week phase III trial.

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SL-1002 for Osteoarthritic Knee Pain (COMPASS Trial)

Phase 2

Waitlist Available

Research Sponsored by Saol Therapeutics Inc

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to month 3 in 11 point nrs score

Summary

This trial tests an injectable medicine called SL-1002 to see if it can reduce knee pain in people with osteoarthritis. The study involves giving patients the medicine and observing the effects. The goal is to find out if a single injection can safely and effectively relieve pain.

Who is the study for?

Adults over 35 with a BMI of 18.0-40.0 kg/m2, experiencing knee pain from osteoarthritis for more than 6 months, and not responding to conservative treatments can join this trial. They must have moderate knee arthritis confirmed by imaging, stable medication use, and agree to contraception if applicable. Exclusions include inflammatory conditions like rheumatoid arthritis, recent joint injections or surgery on the knee, drug abuse history, significant heart or lab abnormalities.

What is being tested?

The study is testing SL-1002's safety and effectiveness in reducing knee pain due to osteoarthritis compared to a placebo. It involves two phases: an initial dose escalation with three groups (24 patients total) followed by a larger phase with up to 108 patients receiving the best dose found in Phase A. Participants are randomly assigned either SL-1002 or placebo at a ratio of 3:1.

What are the potential side effects?

While specific side effects aren't listed here, common risks may include injection site reactions such as pain or swelling, allergic reactions to components of the treatment or placebo, potential worsening of knee symptoms initially after injection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to month 3 in 11 point nrs score

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to month 3 in 11 point nrs score

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to month 3 in 11 point nrs score for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement of knee pain

Occurrence of treatment emergent adverse events (TEAEs) overall

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SL-1002Experimental Treatment1 Intervention

SL-1002 injectable solution, single dose

Group II: Matching placeboPlacebo Group1 Intervention

Matching placebo injectable solution

Do I qualify?Apply below to find out

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), intraarticular glucocorticoid injections, and investigational therapies like platelet-rich plasma (PRP) and gene therapy. NSAIDs work by reducing inflammation and pain through the inhibition of cyclooxygenase enzymes, which are involved in the inflammatory process. Intraarticular glucocorticoid injections provide localized anti-inflammatory effects, offering short-term pain relief by reducing synovial inflammation. PRP aims to promote tissue repair and reduce inflammation through the concentrated delivery of growth factors, although its efficacy is still under investigation. Gene therapy, such as TissueGene-C, targets cellular pathways to enhance cartilage repair and reduce pain. These treatments are crucial for OA patients as they address pain management and inflammation, improving quality of life and joint function.

Comparative efficacy and safety of injection therapies for knee osteoarthritis: A protocol for systematic review and Bayesian network meta analysis.Comparative effectiveness of pharmacologic interventions for knee osteoarthritis: a systematic review and network meta-analysis.