What is the mechanism of action of this treatment?

Common treatments for pain, particularly in conditions like osteoarthritis, include nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics. NSAIDs, such as ibuprofen and naproxen, work by inhibiting cyclooxygenase (COX) enzymes, which play a key role in the production of pro-inflammatory prostaglandins. This reduces inflammation and alleviates pain. Analgesics like acetaminophen act centrally to inhibit pain signals in the brain. These mechanisms are important for pain patients as they directly address the sources of pain and inflammation, providing relief and improving quality of life.

What side effects are associated with this type of intervention?

Common treatments for pain relief in osteoarthritis, such as NSAIDs and COX-2 inhibitors, are associated with several side effects. NSAIDs can cause gastrointestinal issues like ulcers and bleeding, especially with long-term use. They also pose cardiovascular risks, including increased chances of myocardial infarction and hypertension. Renal side effects, such as blood pressure destabilization and edema, are also noted. COX-2 inhibitors, while potentially causing fewer gastrointestinal problems, still carry cardiovascular risks. Patients should use these medications under medical supervision to manage these potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved several nonsteroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors for the treatment of pain, particularly in conditions like osteoarthritis. Commonly approved NSAIDs include ibuprofen, diclofenac, and naproxen, which are effective in reducing pain and inflammation. Celecoxib, a COX-2 inhibitor, is also approved and has shown significant efficacy in managing osteoarthritis pain with a potentially lower risk of gastrointestinal side effects compared to nonselective NSAIDs. These medications are widely used to manage moderate to severe pain associated with osteoarthritis.

What other types of research exist?

Promising alternatives to GSK3858279 for osteoarthritis pain relief include: 1) Floctafenine, a non-narcotic analgesic, which has shown efficacy in a placebo-controlled trial. 2) GW406381, a cyclooxygenase-2 inhibitor, which has demonstrated pain relief in osteoarthritis and acute pain models. 3) PTK787/ZK222584, a VEGF receptor tyrosine kinase inhibitor, which has shown significant anti-arthritic effects in rheumatoid arthritis models. 4) P38 MAP kinase inhibitors like SB-203580 and VX-745, which have shown significant inhibition of joint degeneration and pain relief in preclinical models.

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GSK3858279 for Osteoarthritis Pain (MARS-17 Trial)

Phase 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

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 up to 31 weeks

Summary

This trial is testing a new medication called GSK3858279 to find the best dose for reducing knee pain in people with moderate to severe osteoarthritis. The goal is to determine how much of the medication is needed to be effective and safe. This will help in managing knee pain better for those who suffer from this condition.

Who is the study for?

Adults aged 40-80 with moderate to severe knee osteoarthritis pain, meeting specific clinical criteria and having a BMI under 40. Excluded are those with recent significant knee/hip trauma or surgery, certain cardiovascular, renal, gastrointestinal disorders, immunodeficiency diseases, active tuberculosis, recent malignancy (except certain skin cancers), liver abnormalities or drug allergies.

What is being tested?

The trial is testing different doses of GSK3858279 compared to a placebo in adults with knee osteoarthritis pain. The goal is to find the most effective and safe dose for reducing pain associated with osteoarthritis.

What are the potential side effects?

While not specified here, potential side effects may include reactions at the injection site if applicable, gastrointestinal issues like nausea or diarrhea, headaches, dizziness or allergic reactions among others based on similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 31 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 31 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 31 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline at Week 12 in weekly average of average daily knee pain intensity, assessed on the Numeric Rating Scale (NRS)

Secondary study objectives

Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279

Average concentration over a dosing interval (Cavg) of GSK3858279

Change from baseline at Week 12 in WOMAC function subscale score

+8 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: GSK3858279 Dose 4Experimental Treatment1 Intervention

Participants will receive GSK3858279 dose 4.

Group II: GSK3858279 Dose 3Experimental Treatment1 Intervention

Participants will receive GSK3858279 dose 3.

Group III: GSK3858279 Dose 2Experimental Treatment1 Intervention

Participants will receive GSK3858279 dose 2.

Group IV: GSK3858279 Dose 1Experimental Treatment1 Intervention

Participants will receive GSK3858279 dose 1.

Group V: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GSK3858279

2022

Completed Phase 1

~40

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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 pain, particularly in conditions like osteoarthritis, include nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics. NSAIDs, such as ibuprofen and naproxen, work by inhibiting cyclooxygenase (COX) enzymes, which play a key role in the production of pro-inflammatory prostaglandins. This reduces inflammation and alleviates pain. Analgesics like acetaminophen act centrally to inhibit pain signals in the brain. These mechanisms are important for pain patients as they directly address the sources of pain and inflammation, providing relief and improving quality of life.

An open study of diflunisal, conservative and manipulative therapy in the management of acute mechanical low back pain.Use of nonsteroidal anti-inflammatory drugs in cancer.Nonsteroidal anti-inflammatory drugs and pain in cancer patients: a systematic review and reappraisal of the evidence.