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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 is a Phase 3 study that has completed, run by Omeros Corporation. The registered enrollment target is 321 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00226759
The ClinicalTrials.gov registry entry for NCT00226759 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 321 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Omeros Corporation, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT00226759 reports 0 study locations.
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.
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