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

Primary Purpose

Knee Injuries

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
OMS103HP
Vehicle
Sponsored by
Omeros Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring Anterior cruciate ligament reconstruction, ACL reconstruction

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CORE Orthopaedic Medical Center
  • Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
  • Stanford University
  • Colorado Orthopedic Consultants, PC
  • American Clinical Research Services
  • University of Florida
  • Southeastern Center for Clinical Trials
  • Minnesota Sports Medicine
  • Ohio State University
  • University Orthopedics Center
  • University of Pittsburgh Medical Center
  • University Orthopedics Center
  • Texas Orthopedics
  • Round Rock Orthopedics
  • Unlimited Research
  • Hill Country Sports Medicine
  • Naval Medical Center - Portsmouth
  • Madigan Army Medical Center
  • Rouge Valley Health Systems
  • Hotel Dieu Grace Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OMS103HP irrigation solution

vehicle irrigation solution

Arm Description

Drug

Vehicle

Outcomes

Primary Outcome Measures

Improvement in knee function

Secondary Outcome Measures

Decreased pain
Improved range of motion
Earlier return to work

Full Information

First Posted
September 26, 2005
Last Updated
October 10, 2012
Sponsor
Omeros Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00226759
Brief Title
Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
Official Title
Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Allograft ACL Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omeros Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
Anterior cruciate ligament reconstruction, ACL reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMS103HP irrigation solution
Arm Type
Experimental
Arm Description
Drug
Arm Title
vehicle irrigation solution
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
OMS103HP
Intervention Description
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
Primary Outcome Measure Information:
Title
Improvement in knee function
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Decreased pain
Time Frame
30 days
Title
Improved range of motion
Time Frame
30 days
Title
Earlier return to work
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Houston
Organizational Affiliation
Omeros Corporation
Official's Role
Study Director
Facility Information:
Facility Name
CORE Orthopaedic Medical Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Colorado Orthopedic Consultants, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
American Clinical Research Services
City
Steamboat Springs
State/Province
Colorado
ZIP/Postal Code
80487
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Southeastern Center for Clinical Trials
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30350
Country
United States
Facility Name
Minnesota Sports Medicine
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
University Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Texas Orthopedics
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Round Rock Orthopedics
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Unlimited Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Hill Country Sports Medicine
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Naval Medical Center - Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Rouge Valley Health Systems
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Facility Name
Hotel Dieu Grace Hospital
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1E1
Country
Canada

12. IPD Sharing Statement

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

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