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

Sponsored by:	Omeros Corporation
Information provided by:	Omeros Corporation
ClinicalTrials.gov Identifier:	NCT00226772

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 using a hamstring autograft. 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 Autograft 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:	June 2005
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 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 a medial hamstring (semitendinosus and gracilis) autograft
Able to participate in the study rehabilitation protocol
and other inclusion criteria

Exclusion Criteria:

Allergies to any of the individual ingredients in OMS103HP
Taking medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
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: NCT00226772

Locations

United States, California
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
Advanced Orthopedic and Sports Medicine Specialists	Recruiting
Denver, Colorado, United States, 80230
Contact: Rebecca Dartman 303-895-8197 beaker311_2000@yahoo.com
Principal Investigator: John D Papilion, MD
United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32611
Contact: Chris Koenig, MS, ATC/L 352-273-7372 koenicj@ortho.ufl.edu
Principal Investigator: Peter Indelicato, MD
United States, Georgia
Emory Orthopaedics & Spine Center	Recruiting
Atlanta, Georgia, United States, 30329
Contact: Kyle Webb 404-778-6381 kyle.webb@emoryhealthcare.org
Principal Investigator: John Xerogeanes, MD
United States, Michigan
William Beaumont Hospital	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Melissa Lurie, RN 248-551-6679 mlurie@beaumont.edu
Principal Investigator: Joseph Guettler, MD
United States, Minnesota
Minnesota Sports Medicine	Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Russell Giveans 612-273-4811 mgivean1@Fairview.org
Principal Investigator: Christopher Larson, MD
United States, North Carolina
Duke University	Recruiting
Durham,, North Carolina, United States, 27710
Contact: Libby Pennington, RN 919-684-6071 elizabeth.pennington@duke.edu
Principal Investigator: William Garrett, Jr,, MD, PhD
Triangle Orthopaedic Associates, PA	Recruiting
Durham, North Carolina, United States, 27704
Contact: Crystal Hill, BSN 919-220-5255 CHill@triangleortho.com
Principal Investigator: David T Dellaero, MD
United States, Ohio
Ohio State University	Recruiting
Columbus, Ohio, United States, 43221
Contact: Breanna Beck 614-293-2410 Beck.261@osu.edu
Principal Investigator: Christopher Kaeding, MD
United States, Pennsylvania
University Orthopedics Center	Recruiting
State College, Pennsylvania, United States, 16801
Contact: Kate Tyson 814-231-2101
Principal Investigator: Thomas Ellis, MD
University Orthopedics Center	Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Robyn Stern 814-231-2101
Principal Investigator: Christopher McClennan, DO
United States, Texas
Unlimited Research	Recruiting
San Antonio, Texas, United States, 78217
Contact: Rhonda Seward 210-477-5160
Principal Investigator: David L Fox, MD
Hill Country Sports Medicine	Recruiting
San Marcos, Texas, United States, 78666
Contact: Melissa Gattis 512-638-3242
Principal Investigator: Gerard M Pennington, MD
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, Alberta
Lifemark Health Research Group	Recruiting
Calgary, Alberta, Canada, T2G 5B6
Contact: Treny Sasyniuk 4032375633
Principal Investigator: Laurie A Hiemstra, MD
Canada, Ontario
Rouge Valley Health System	Recruiting
Ajax, Ontario, Canada, L1S 2J5
Contact: Patricia Dekeseredy 9056860882
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:	C03512
Study First Received:	September 26, 2005
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00226772
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