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

Sponsored by:	Omeros Corporation
Information provided by:	Omeros Corporation
ClinicalTrials.gov Identifier:	NCT00226759

Purpose

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.

Condition	Intervention	Phase
Knee Injuries	Drug: OMS103HP Drug: Vehicle	Phase III

MedlinePlus related topics: Knee Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Allograft ACL Reconstruction

Further study details as provided by Omeros Corporation:

Primary Outcome Measures:

Improvement in knee function [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Decreased pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Improved range of motion [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Earlier return to work [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	November 2004
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Drug	Drug: OMS103HP Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.
2: Placebo Comparator Vehicle	Drug: Vehicle Maximum of 39 liters bags of vehicle irrigation solution over a maximum of 2 hours

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226759

Locations

United States, California
Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)	Recruiting
Redwood City, California, United States, 94063
Contact: Louise Loh 650-995-1250
Principal Investigator: Michael Dillingham, MD
Kerlan-Jobe Orthopaedic Clinic	Recruiting
Los Angeles, California, United States, 90045
Contact: Emily vollmer 310-665-7200
Principal Investigator: Neal S ElAttrache, MD
CORE Orthopedics	Recruiting
Encinitas, California, United States, 92024
Contact: Farouk Awad 760-943-6700 fawad@COREOrthopaedic.com
Principal Investigator: Michael Skyhar, MD
United States, Colorado
Colorado Orthopedic Consultants, PC	Recruiting
Englewood, Colorado, United States, 80110
Contact: Renae Jackson 303-671-2149 rjackson@cocortho.com
Principal Investigator: Philip A Stull, MD
American Clinical Research Services	Recruiting
Steamboat Springs, Colorado, United States, 80487
Contact: Anna Petri 970-879-9911
Principal Investigator: Eric Verploeg, MD
United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32611
Contact: Chris Koenig, MS, ATC/L koenicj@ortho.ufl.edu
Principal Investigator: Peter Indelicato, MD
United States, Georgia
Southeastern Center for Clinical Trials	Recruiting
Atlanta, Georgia, United States, 30350
Contact: George Rainey, MD 404-216-7099
Principal Investigator: Maurice Jove, MD
United States, Minnesota
Minnesota Sports Medicine	Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Russell Giveans mgivean1@Fairview.org
Principal Investigator: Christopher Larson, MD
United States, North Carolina
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Martha Holden mholden@wfubmc.edu
Principal Investigator: Gary G Poehling, MD
United States, Ohio
Ohio State University	Recruiting
Columbus, Ohio, United States, 43221
Contact: Breanna Beck Beck.261@osu.edu
Principal Investigator: Christopher Kaeding, MD
United States, Pennsylvania
University of Pittsburgh Medical Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15203
Contact: Matthew Bottegal 412-432-3619 bottegalmt@anes.upmc.edu
Principal Investigator: Christopher Harner, MD
University Orthopedics Center	Recruiting
State College, Pennsylvania, United States, 16801
Contact: Kate Tyson 814-231-2101 ktyson@uoc.com
Principal Investigator: Thomas Ellis, MD
University Orthopedics Center	Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Robyn Stern 814-231-2101 rstern@uoc.com
Principal Investigator: Christopher McClennan, DO
United States, Texas
Hill Country Sports Medicine	Recruiting
San Marcos, Texas, United States, 78666
Contact: Melissa Gattis 512-353-8661 mag@hccrsite.com
Principal Investigator: Gerard M Pennington, MD
Unlimited Research	Recruiting
San Antonio, Texas, United States, 78217
Contact: Rhonda Seward 210-447-5160 rseward@unlimitedresearchtx.com
Principal Investigator: David Fox, MD
Plano Orthopedic Sports Medicine and Spine Center	Recruiting
Plano, Texas, United States, 75093
Contact: Jennifer Heldreth 972-250-5700
Principal Investigator: Alan F Barber
Sports Medicine Associates of San Antonio	Recruiting
San Antonio, Texas, United States, 78229
Contact: Lisa Rodriquez 210-343-0807
Principal Investigator: David Schmidt, MD
Texas Orthopedics	Recruiting
Austin, Texas, United States, 78759
Contact: Melissa Gattis 512-439-1011
Principal Investigator: Gerard M Pennington, MD
Canada, Ontario
Rouge Valley Health System	Recruiting
Ajax, Ontario, Canada, L1S 2J5
Contact: Patricia Dekeseredy 905.686.0882
Principal Investigator: Fathi Abuzgaya, MD

Sponsors and Collaborators

Omeros Corporation

Investigators

Study Director:

Paul Strauss, MD

Omeros Corporation

More Information

Responsible Party:	Omeros Corporation ( Gregory Demopulos, MD, CEO, CMO )
Study ID Numbers:	C03511
Study First Received:	September 26, 2005
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00226759
Health Authority:	United States: Food and Drug Administration

Keywords provided by Omeros Corporation:

Anterior cruciate ligament reconstruction
ACL reconstruction

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Knee Injuries
Leg Injuries

ClinicalTrials.gov processed this record on January 16, 2009