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

Knee Injuries Clinical Trial

Official title:

Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Allograft ACL Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226759
• Other study ID #: C03511
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2005
• Last updated: October 10, 2012
• Start date: November 2004
• Est. completion date: March 2011

Study information

• Verified date: October 2012
• Source: Omeros Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: March 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• 15 - 65 years of age

• In good general health with an ACL tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery

• Undergoing primary unilateral ACL reconstruction using an allograft (patellar tendon bone, Achilles tendon, tibialis tendon, or hamstring)

• Able to participate in the study rehabilitation protocol

• and other inclusion criteria

Exclusion Criteria:

• No allergies to any of the individual ingredients in OMS103HP

• No medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery

• No associated knee injuries likely to interfere with evaluation of the study drug

• and other exclusion criteria

Study Design

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

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Drug:
• OMS103HP
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.
• Vehicle
Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours

Locations

Country	Name	City	State
Canada	Rouge Valley Health Systems	Ajax	Ontario
Canada	Hotel Dieu Grace Hospital	Windsor	Ontario
United States	University Orthopedics Center	Altoona	Pennsylvania
United States	Southeastern Center for Clinical Trials	Atlanta	Georgia
United States	Texas Orthopedics	Austin	Texas
United States	Ohio State University	Columbus	Ohio
United States	CORE Orthopaedic Medical Center	Encinitas	California
United States	Colorado Orthopedic Consultants, PC	Englewood	Colorado
United States	University of Florida	Gainesville	Florida
United States	Minnesota Sports Medicine	Minneapolis	Minnesota
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Naval Medical Center - Portsmouth	Portsmouth	Virginia
United States	Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)	Redwood City	California
United States	Round Rock Orthopedics	Round Rock	Texas
United States	Unlimited Research	San Antonio	Texas
United States	Hill Country Sports Medicine	San Marcos	Texas
United States	Stanford University	Stanford	California
United States	University Orthopedics Center	State College	Pennsylvania
United States	American Clinical Research Services	Steamboat Springs	Colorado
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Omeros Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in knee function		30 days	No
Secondary	Decreased pain		30 days	No
Secondary	Improved range of motion		30 days	No
Secondary	Earlier return to work		30 days	No