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NCT00226759 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
A Phase 3 study, sponsored by Omeros Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 321
- Enrollment target
NCT00226759: Completed Phase 3 study, sponsored by Omeros Corporation.
NCT00226759 is a Phase 3 study that has completed, run by Omeros Corporation. The registered enrollment target is 321 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00226759, a Phase 3 study, has completed, sponsored by Omeros Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 321 participants
- Enrollment target
Study Summary
The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. OMS103HP was designed to deliver targeted therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit inflammation and pain before they can begin. The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion and earlier return to work.
Interventions
- DRUG Vehicle
- DRUG OMS103HP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2004-11 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
What the finished NCT00226759 record still lists
NCT00226759 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT00226759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00226759 about?
NCT00226759 is a clinical study titled "Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction". The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of funct...
What is the current status of trial NCT00226759?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 321 participants. The study started on 2004-11. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00226759?
The interventions under investigation include: Vehicle (DRUG), OMS103HP (DRUG).
Who is sponsoring clinical trial NCT00226759?
This trial is sponsored by Omeros Corporation, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00226759's enrollment target sits among peer trials
321 1081st of 2000 higher than 919 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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