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

Phase 3

Completed

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Drug: OMS103HP; Drug: Vehicle

• Registration Number: NCT00245271
• Lead Sponsor: Omeros Corporation

Brief 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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-27
• Primary Completion: 2010-03
• Study Completion: 2011-03
• Status Verified: 2011-06
• Disposition First Submitted: 2011-06-17
• Disposition First Submitted QC: 2011-06-17
• Last Update Submitted: 2011-06-17
• Disposition First Posted: 2011-06-27
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• 17 - 65 years of age
• In good general health
• Undergoing arthroscopic ACL reconstruction for an ACL tear

Exclusion Criteria

• Allergies to any of the individual ingredients in OMS103HP
• Has open physes in the distal femur or proximal tibia
• Undergoing bilateral knee surgery
• Subject who is considered by Investigator to be an unsuitable candidate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	OMS103HP	OMS103 Irrigation Solution
2	Vehicle	Balanced Salt Solution (BSS)

Primary Outcome Measures

Name	Time	Method
The overall incidence of adverse events regardless of relationship to study drug.	90 days

Secondary Outcome Measures

Name	Time	Method
Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.).	30 days

Trial Locations

Locations (10)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Advanced Orthopedic and Sports Medicine Specialists; 🇺🇸 Denver, Colorado, United States

Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.); 🇺🇸 Redwood City, California, United States

Kerlan-Jobe Orthopaedic Clinic; 🇺🇸 Los Angeles, California, United States

Colorado Orthopedic Consultants, PC; 🇺🇸 Englewood, Colorado, United States

Rush University; 🇺🇸 Chicago, Illinois, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Ohio State University Sports Medicine; 🇺🇸 Columbus, Ohio, United States

Temple University Orthopedics; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States