GSK3858279 for Osteoarthritis Pain
(MARS-17 Trial)

Recruiting in Palo Alto (17 mi)

+100 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: GlaxoSmithKline

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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.

Inclusion Criteria

My knee X-ray shows moderate to severe arthritis.

I am between 40 and 80 years old.

My daily pain level is between 4 and 9 on a scale of 0 to 10.

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Exclusion Criteria

I have not had major knee or hip surgery or injury in the past 6 months.

I don't have heart, kidney, stomach, or lymph system problems that would affect the study.

My kidney function is reduced, with a creatinine clearance below 60 mL/min.

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Treatment Details

Interventions

GSK3858279 (Other)
Placebo (Other)

Trial OverviewThe 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.

Participant Groups

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.