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Corticosteroid

Oral Steroids for Osteoarthritis Pain

Phase 4
Waitlist Available
Led By Brent Becker, MD
Research Sponsored by WellSpan Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Acute monoarticular arthritic joint pain affecting native knee, hip, or shoulder presumed to be related to osteoarthritis
Must not have
Prior arthroplasty of the affected joint
Daily prescription opioid use or active opioid use disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days (72 hours)
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial aims to see if adding steroids to standard pain medication can better relieve joint pain from osteoarthritis. Participants will be divided into three groups: one with a placebo and pain medication, one

Who is the study for?
Adults with joint pain from osteoarthritis visiting the emergency department can join. They'll be testing if adding steroids to standard pain meds helps more than just pain meds alone.
What is being tested?
The trial is checking if oral steroids (Prednisone or Dexamethasone) plus ibuprofen relieve osteoarthritis pain better than placebo pills with ibuprofen. Participants are randomly assigned to one of three groups and followed up for two weeks.
What are the potential side effects?
Steroids like Prednisone and Dexamethasone might cause mood changes, increased blood sugar levels, appetite changes, trouble sleeping, and higher infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have severe joint pain in my knee, hip, or shoulder due to arthritis.
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I am scheduled to be discharged from the emergency department.
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My X-rays show I have osteoarthritis in my joint.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had joint replacement surgery on the affected joint.
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I use prescription opioids daily or have an opioid addiction.
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I cannot take ibuprofen/NSAIDs or steroids due to other health reasons.
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I am scheduled to be admitted to the hospital from the emergency department.
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I have a history of heart, stomach, kidney issues, or blood disorders.
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I am allergic to ibuprofen, prednisone, dexamethasone, or similar medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days (72 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days (72 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events (Safety Outcome)
Change in Resting Pain Score at 3 Days (Effectiveness Outcome)
Secondary study objectives
Change in Ambulatory/Active Movement Pain Score at 1 Day
Change in Ambulatory/Active Movement Pain Score at 14 Days
Change in Ambulatory/Active Movement Pain Score at 3 Days
+5 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Intervention A - PrednisoneActive Control1 Intervention
Subjects assigned to the Intervention A group will receive prednisone 50 mg once a day for 5 days, plus ibuprofen 600 mg every 8 hours for 5 days.
Group II: Intervention B - DexamethasoneActive Control1 Intervention
Subjects assigned to the Intervention B group will receive a single dose of dexamethasone 10 mg, plus ibuprofen 600 mg every 8 hours for 5 days.
Group III: Control - PlaceboPlacebo Group1 Intervention
Subjects assigned to the Control group will receive placebo once a day for 5 days, plus ibuprofen 600 mg every 8 hours for 5 days.

Find a Location

Who is running the clinical trial?

WellSpan HealthLead Sponsor
30 Previous Clinical Trials
2,004,668 Total Patients Enrolled
Brent Becker, MDPrincipal InvestigatorWellSpan Health
~128 spots leftby Oct 2027
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