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NCT04504812 · ClinicalTrials.gov registry record · Phase 3
A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain
A Phase 3 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,937
- Enrollment target
NCT04504812: Completed Phase 3 study, sponsored by Johns Hopkins University.
NCT04504812 is a Phase 3 study that has completed, run by Johns Hopkins University. The registered enrollment target is 1,937 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (151% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04504812, a Phase 3 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,937 participants
- Enrollment target
Study Summary
There is an urgent public health need to reduce reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA.These results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-surgical alternatives.
Primary Outcome
The Modified 4-item BPI Pain scale consists of 3 items from BPI Pain Intensity and 1 item from BPI Pain Interference. This is a continuous measure that will be calculated as the average of worst, average, current knee pain, and pain upon walking. Change from baseline (BL) will be used in mITT analyses, and change from treatment will be used in per protocol analyses.
Interventions
- DRUG Duloxetine
- COMBINATION_PRODUCT Intra-Articular Injection
- PROCEDURE Nerve Procedure with long acting blocks
- PROCEDURE Nerve Procedure with nerve ablation
- BEHAVIORAL Pain Coping Skills Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,937 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2025-04-08 |
| Phase | Phase 3 |
What the finished NCT04504812 record still lists
NCT04504812 is an interventional study that assigns participants to a tested intervention. Its 1,937 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (151% higher).
The record links to 0 conditions, and to 5 interventions - of which Duloxetine is the first listed.
NCT04504812 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04504812 about?
NCT04504812 is a clinical study titled "A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain". There is an urgent public health need to reduce reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA.These results will lead to im...
What is the current status of trial NCT04504812?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,937 participants. The study started on 2021-02-01. Estimated completion is 2025-04-08.
What interventions are being tested in trial NCT04504812?
The interventions under investigation include: Duloxetine (DRUG), Intra-Articular Injection (COMBINATION_PRODUCT), Nerve Procedure with long acting blocks (PROCEDURE), Nerve Procedure with nerve ablation (PROCEDURE), Pain Coping Skills Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04504812?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04504812's enrollment target sits among peer trials
1,937 109th of 2000 higher than 1,892 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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