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NCT06603662 · ClinicalTrials.gov registry record · Phase 4
Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department
A Phase 4 study of Osteoarthritis and Osteoarthritis (OA) of the Knee, sponsored by WellSpan Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 192
- Enrollment target
- 1
- Study location
NCT06603662 is a Phase 4 study of Osteoarthritis and Osteoarthritis (OA) of the Knee that is actively recruiting participants, run by WellSpan Health. The registered enrollment target is 192 participants, below the 816-participant average among 135 other Osteoarthritis trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06603662, a Phase 4 study of Osteoarthritis and Osteoarthritis (OA) of the Knee, is actively recruiting participants, sponsored by WellSpan Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 192 participants
- Enrollment target
- 1
- Study location
Study Summary
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. In brief, the central aims of the study are to: 1. Assess the efficacy of adding oral glucocorticoid medications to the standard pain medications used to treat the pain of osteoarthritis. 2. Assess the safety and tolerability of oral glucocorticoid medication for the short-term treatment of osteoarthritis pain. We hypothesize that: 1) The addition of glucocorticoids to standard pain medications will improve reported pain scores at 3 days following the initiation of treatment compared to standard pain medications alone and 2) The use of glucocorticoids will be well tolerated. Participants in the study will be randomized (like flipping a coin) into one of three groups: 1. Study Group 1 (Control) receiving placebo pills (no active ingredient) once a day for 5 days, plus ibuprofen (pain medication) for 5 days. 2. Study Group 2 (Intervention A) who will receive prednisone (steroid) once a day for 5 days, plus ibuprofen (pain medication) for 5 days. 3. Study Group 3 (Intervention B) who will receive one dose of dexamethasone (steroid) followed by placebo pills (no active ingredient) once a day for 4 days, plus ibuprofen (pain medication) for 5 days. In all groups, acetaminophen (a different pain medication) can be taken as needed for pain that is not controlled with ibuprofen. Participants will: * Receive follow up phone calls at 1, 3, 7 and 14 days. * Report pain scores related to joint pain. * Report the number of pills taken of the various medications used in the study. * Report any adverse events incurred during the follow up period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dexamethasone
- DRUG Prednisone
Study Locations (1)
Pennsylvania
- WellSpan York Hospital - York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2027-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06603662
The ClinicalTrials.gov registry entry for NCT06603662 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 816-participant average among 135 other Osteoarthritis trials with a reported enrollment target (76% lower). The listed sponsor is WellSpan Health, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Osteoarthritis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06603662 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06603662 about?
NCT06603662 is a clinical study titled "Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department". 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 in...
What is the current status of trial NCT06603662?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 192 participants. The study started on 2025-02-24. Estimated completion is 2027-12.
What conditions does trial NCT06603662 study?
This clinical trial studies the following conditions: Osteoarthritis, Osteoarthritis (OA) of the Knee, Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Shoulder.
What interventions are being tested in trial NCT06603662?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Prednisone (DRUG).
Who is sponsoring clinical trial NCT06603662?
This trial is sponsored by WellSpan Health, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06603662 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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