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

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

Resource links provided by NLM:

MedlinePlus related topics: Knee Injuries and Disorders Surgery

U.S. FDA Resources

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:	March 2010
Estimated Primary Completion Date:	March 2010 (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 Orthopaedic Medical Center	Recruiting
Encinitas, California, United States, 92024
Contact: Farouk Awad 760-943-6710 ext 162 fawad@COREOrthopaedic.com
Principal Investigator: Michael Skyhar, MD
United States, Colorado
Colorado Orthopedic Consultants, PC	Recruiting
Englewood, Colorado, United States, 80110
Contact: Khalis Mitchell 303-695-6060 ext 269 kmitchell@cocortho.com
Principal Investigator: Philip A. Stull, MD
Advanced Orthopedic and Sports Medicine Specialists	Recruiting
Denver, Colorado, United States, 80230
Contact: Julie Knight 303-260-9650 juliemknight@hotmail.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: Michael Moser, MD
United States, Michigan
William Beaumont Hospital	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Melissa Lurie, RN 248-898-5000 mlurie@beaumont.edu
Principal Investigator: Joseph Guettler, MD
United States, Minnesota
Minnesota Sports Medicine	Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Russell Giveans, PhD 612-625-0783 mgivean1@Fairview.org
Principal Investigator: Christopher Larson, 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 - Altoona	Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Robin Stern 814-231-2101 rstern@uoc.com
Principal Investigator: Christopher McClellan, DO
United States, Texas
Unlimited Research	Recruiting
San Antonio, Texas, United States, 78217
Contact: Geany Bradley 210-477-5160 gbradley@unlimitedresearchtx.com
Principal Investigator: David L. Fox, MD
Hill Country Sports Medicine	Recruiting
San Marcos, Texas, United States, 78666
Contact: Melissa Gattis 512-638-3242 mag@hccrsite.com
Principal Investigator: Marc DeHart, MD
Texas Orthopedics	Recruiting
Austin, Texas, United States, 78759
Contact: Melissa Gattis 512-638-3242 mag@hccrsite.com
Principal Investigator: Marc DeHart, MD
Round Rock Orthopedics	Recruiting
Round Rock, Texas, United States, 78681
Contact: Melissa Gattis 512-638-3242 mag@hccrsite.com
Principal Investigator: Marc DeHart, MD
Basin Orthopedic Surgical Specialists	Recruiting
Odessa, Texas, United States, 79761
Contact: Deborah L. Mossbarger 432-332-2663 bossresearch@hotmail.com
Principal Investigator: Steven Riley, MD
United States, Virginia
Naval Medical Center - Portsmouth	Recruiting
Portsmouth, Virginia, United States, 23708
Contact: Tangerica Alexander tangerica.alexander@med.navy.mil
Principal Investigator: Marlene DeMaio, MD
United States, Washington
Madigan Army Medical Center	Recruiting
Tacoma, Washington, United States, 98431
Contact: Erinn Morris 253-968-3121
Principal Investigator: Edward D. Arrington
Canada, Alberta
Lifemark Health Research Group	Recruiting
Calgary, Alberta, Canada, T2G 5B6
Contact: Treny Sasyniuk 403-237-5633 sasyniuk@alumni.ucalgary.ca
Principal Investigator: Laurie A. Hiemstra, MD
Canada, Ontario
Rouge Valley Health Systems	Recruiting
Ajax, Ontario, Canada, L1S 2J5
Contact: Audrey Gosson 905-686-4314 agosson@adamedical.com
Principal Investigator: Fathi Abuzgaya, MD
Fowler Kennedy Sport Medicine Clinic	Recruiting
London, Ontario, Canada, N6A 3K7
Contact: Sharon Griffin s.griffin@uwo.ca
Principal Investigator: J. Robert Giffin, MD

Sponsors and Collaborators

Omeros Corporation

Investigators

Study Director:

Stephen R. Murray, MD, PhD

Omeros Corporation

More Information

No publications provided

Responsible Party:	Omeros Corporation ( Gregory Demopulos, MD, CEO, CMO )
Study ID Numbers:	C03512
Study First Received:	September 26, 2005
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00226772 History of Changes
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

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Knee Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 11, 2009