Recruiting PHASE4 Osteoarthritis

New treatment option for Osteoarthritis

Official title Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department

ClinicalTrials.gov ID: NCT06603662

What this study is testing

What is Prednisone?

Prednisone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for osteoarthritis.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The purpose of this clinical trial is to compare the analgesic effects (relief of pain) of glucocorticoids (steroids) and pain medication versus pain medication alone in adult patients presenting to the emergency department with joint pain due to osteoarthritis. Steroids are drugs that can reduce inflammation and are used commonly for many different medical conditions.
  • Phase 4: studies an already-approved treatment
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥18 years
  • Acute monoarticular arthritic joint pain affecting native knee, hip, or shoulder presumed to be related to osteoarthritis
  • Acute pain above baseline starting less than 72 hour prior to ED visit
  • Planned discharge from the ED
  • History of osteoarthritis of the affected joint based on radiography performed at index visit or prior available imaging

You likely can't join if

  • Trauma to the affected joint within 30 days
  • Injection of affected joint within 60 days
  • Prior arthroplasty of the affected joint
  • History of coronary artery disease, severe gastrointestinal bleeding, gastric/peptic ulcer disease, chronic kidney disease with GFR less than 30, or...
  • Joint pain suspected to be related to rheumatoid arthritis, gout, septic arthritis, or other non-osteoarthritis autoimmune/inflammatory/infectious...
  • Chronic/baseline use of glucocorticoids (greater than 5 mg daily prednisone or equivalent within previous 7 days) or NSAIDs (daily use for more than...
See the full eligibility criteria
Who can join
  • Age ≥18 years
  • Acute monoarticular arthritic joint pain affecting native knee, hip, or shoulder presumed to be related to osteoarthritis
  • Acute pain above baseline starting less than 72 hour prior to ED visit
  • Planned discharge from the ED
  • History of osteoarthritis of the affected joint based on radiography performed at index visit or prior available imaging
What rules you out
  • Trauma to the affected joint within 30 days
  • Injection of affected joint within 60 days
  • Prior arthroplasty of the affected joint
  • History of coronary artery disease, severe gastrointestinal bleeding, gastric/peptic ulcer disease, chronic kidney disease with GFR less than 30, or platelet disorders (including von Willebrand disease, hemophilia...
  • Joint pain suspected to be related to rheumatoid arthritis, gout, septic arthritis, or other non-osteoarthritis autoimmune/inflammatory/infectious arthritis
  • Chronic/baseline use of glucocorticoids (greater than 5 mg daily prednisone or equivalent within previous 7 days) or NSAIDs (daily use for more than 2 days prior to presentation)
  • Daily prescription opioid use or active opioid use disorder
  • Illicit drug use
  • Known allergy/intolerance to ibuprofen/NSAIDs, prednisone, dexamethasone, or other medication precluding ability to participate in one or more study arms
  • Other contraindications to ibuprofen/NSAIDs or glucocorticoids
  • Planned hospitalization from the ED
  • Pregnancy
  • Incarceration
  • Inability to provide informed consent
  • Other conditions that would preclude compliance with the study protocol and medication dosing

The study team makes the final eligibility decision.

Where it's taking place

  • York, Pennsylvania, United States

Compensation & support

Some study costs may be covered.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include York, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.