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

This study has been completed.
Sponsor:
Information provided by:
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT00245271
First received: October 26, 2005
Last updated: June 17, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Anterior Cruciate Ligament Reconstruction
 Drug: OMS103HP
Drug: Vehicle
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Omeros Corporation:

Primary Outcome Measures:
  • The overall incidence of adverse events regardless of relationship to study drug. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 480
Study Start Date: October 2004
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
OMS103 Irrigation Solution
 Drug: OMS103HP
Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours
Placebo Comparator: 2
Balanced Salt Solution (BSS)
 Drug: Vehicle
Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.

Detailed 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.

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245271

Locations
United States, California
Kerlan-Jobe Orthopaedic Clinic
Los Angeles, California, United States, 90045
Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
Redwood City, California, United States, 94063
United States, Colorado
Advanced Orthopedic and Sports Medicine Specialists
Denver, Colorado, United States, 80230
Colorado Orthopedic Consultants, PC
Englewood, Colorado, United States, 80110
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Ohio State University Sports Medicine
Columbus, Ohio, United States, 43221
United States, Pennsylvania
Temple University Orthopedics
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15203
Sponsors and Collaborators
Omeros Corporation
Investigators
Study Director: Scott Houston Omeros Corporation
  More Information

No publications provided

Responsible Party: Gregory Demopulos, MD, CEO, CMO, Omeros Corporation
ClinicalTrials.gov Identifier: NCT00245271     History of Changes
Other Study ID Numbers: C04516
Study First Received: October 26, 2005
Last Updated: June 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Omeros Corporation:
Knee
Musculoskeletal System
Ligament
ACL reconstruction

ClinicalTrials.gov processed this record on May 23, 2013