NCT00245271

Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction

Double-Blind, Multicenter Study Evaluating the Safety of OMS103HP and Vehicle in Subjects Undergoing Anterior Cruciate Ligament Reconstruction With an Open-Label Phase Containing a PK Analysis in a Subset of Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 17 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

OMS103HP is being developed for improvement in knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee motion and earlier return to work.

Detailed description

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. Because of the dynamic nature, complexity and redundancy of the chemical mediators of inflammation and pain and their pathways, no currently available single drug has sufficiently broad spectrum of activity to effectively inhibit the inflammatory process. OMS103 provides a multicomponent approach to controlling the inflammation induced by arthroscopic surgery. It delivers three active ingredients, each with distinct pharmacological activities, directly to the site of surgical procedures to preemptively block the inflammatory cascade induced by surgical trauma.

Conditions

• Anterior Cruciate Ligament Reconstruction

Interventions

Type	Name	Description
DRUG	OMS103HP	Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours
DRUG	Vehicle	Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.

Timeline

• Start date: 2004-10-01
• Primary completion: 2010-03-01
• Completion: 2011-03-01
• First posted: 2005-10-27
• Last updated: 2011-06-27

Locations

10 sites across 1 country: United States