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

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245271
• Other study ID #: C04516
• Status: Completed
• Phase: Phase 3
• First received: October 26, 2005
• Last updated: June 17, 2011
• Start date: October 2004
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Omeros Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Drug:
• OMS103HP
Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours
• Vehicle
Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.

Locations

Country	Name	City	State
United States	Rush University	Chicago	Illinois
United States	Ohio State University Sports Medicine	Columbus	Ohio
United States	Advanced Orthopedic and Sports Medicine Specialists	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Colorado Orthopedic Consultants, PC	Englewood	Colorado
United States	Kerlan-Jobe Orthopaedic Clinic	Los Angeles	California
United States	Temple University Orthopedics	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)	Redwood City	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Omeros Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall incidence of adverse events regardless of relationship to study drug.		90 days	Yes
Secondary	Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.).		30 days	Yes