What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as NSAIDs and COX-2 inhibitors like celecoxib, are associated with several side effects. NSAIDs can cause gastrointestinal issues, including ulcers and bleeding, especially in high-risk patients. They also carry a risk of cardiovascular events such as myocardial infarction and stroke. COX-2 inhibitors may have a slightly lower risk of gastrointestinal complications but still pose cardiovascular risks. Other pain-modulating agents, like those targeting nerve receptors or inflammatory pathways, may have side effects including local pain, swelling, and potential infection at the injection site, as well as systemic effects like altered blood pressure and renal function.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, primarily focusing on pain relief and inflammation reduction. Commonly approved drugs include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, and corticosteroids for intraarticular injections. More recently, biologic agents targeting specific inflammatory pathways, such as tumor necrosis factor (TNF) inhibitors, have been explored. Investigational treatments similar to RTX-GRT7039, which may target nerve receptors or inflammatory pathways, include platelet-rich plasma (PRP) and other novel biologic therapies, though these are still under study and not yet widely approved.

What other types of research exist?

Promising novel alternatives to RTX-GRT7039 for osteoarthritis treatment include: 1) PTK787/ZK222584, a VEGF receptor tyrosine kinase inhibitor that has shown significant anti-arthritic effects in models of rheumatoid arthritis. 2) Grapiprant, a selective EP4 receptor antagonist, which has demonstrated efficacy in reducing pain and inflammation in osteoarthritis models. 3) P38 MAP kinase inhibitors like SB203580 and VX-745, which have shown potential in reducing cartilage degeneration and pain in osteoarthritis models.

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RTX-GRT7039 for Osteoarthritis

Phase 3

Waitlist Available

Research Sponsored by Grünenthal GmbH

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 from baseline up to week 52

Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a new injectable drug for knee pain caused by osteoarthritis.

Who is the study for?

Adults over 18 with knee osteoarthritis who haven't found pain relief from standard treatments can join. They must meet specific criteria for the severity of their condition and not have other knee issues or sensitivities to components like capsaicin. Recent surgery, significant trauma, or participation in another drug trial disqualifies them.Check my eligibility

What is being tested?

The trial is testing RTX-GRT7039 against a placebo in patients with knee osteoarthritis pain. Participants will receive repeated injections to see if it's effective and safe compared to no active treatment. The study randomly assigns participants to either the test drug or placebo group without them knowing which one they're getting.See study design

What are the potential side effects?

While the potential side effects are not listed here, similar compounds like capsaicin may cause local reactions such as burning or stinging at the injection site, increased knee pain, swelling, and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

Secondary outcome measures

Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores

Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score

Change from Baseline in WOMAC A1 (Walking Pain) Subscale Score

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RTX-GRT7039Experimental Treatment1 Intervention

Participants will receive 2 intra-articular injections of RTX-GRT7039 during the 52-week double-blind treatment period.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive 2 intra-articular injections of placebo matching to RTX-GRT7039 during the 52-week double-blind treatment period.

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

Common treatments for osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs), duloxetine, and intraarticular injections. NSAIDs work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), reducing inflammation and pain. Duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI), modulates pain by increasing neurotransmitter levels in the brain and spinal cord. Intraarticular injections, such as corticosteroids, provide localized anti-inflammatory effects. Investigational treatments like platelet-rich plasma (PRP) aim to reduce inflammation and promote tissue repair through growth factors, while gene therapies like TissueGene-C target cellular pathways to improve cartilage health. Understanding these mechanisms helps OA patients and their doctors choose the most appropriate treatment based on the specific pathways involved in their symptoms.

Pathophysiology and first-line treatment of osteoarthritis.A systematic review of randomized controlled trials of pharmacological therapy in osteoarthritis of the hip.

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Who is running the clinical trial?

Grünenthal GmbHLead Sponsor

97 Previous Clinical Trials

33,618 Total Patients Enrolled

12 Trials studying Osteoarthritis

8,808 Patients Enrolled for Osteoarthritis

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05248386 — Phase 3

Osteoarthritis Research Study Groups: RTX-GRT7039, Placebo

Osteoarthritis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05248386 — Phase 3

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05248386 — Phase 3

~164 spots leftby May 2025

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