Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
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
1 other identifier
interventional
480
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Longer than P75 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 26, 2005
CompletedFirst Posted
Study publicly available on registry
October 27, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 27, 2011
June 1, 2011
5.4 years
October 26, 2005
June 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The overall incidence of adverse events regardless of relationship to study drug.
90 days
Secondary Outcomes (1)
Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.).
30 days
Study Arms (2)
1
EXPERIMENTALOMS103 Irrigation Solution
2
PLACEBO COMPARATORBalanced Salt Solution (BSS)
Interventions
Eligibility Criteria
You may qualify if:
- years of age
- In good general health
- Undergoing arthroscopic ACL reconstruction for an ACL tear
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Kerlan-Jobe Orthopaedic Clinic
Los Angeles, California, 90045, United States
Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
Redwood City, California, 94063, United States
Advanced Orthopedic and Sports Medicine Specialists
Denver, Colorado, 80230, United States
Colorado Orthopedic Consultants, PC
Englewood, Colorado, 80110, United States
Rush University
Chicago, Illinois, 60612, United States
Duke University
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Ohio State University Sports Medicine
Columbus, Ohio, 43221, United States
Temple University Orthopedics
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15203, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Scott Houston
Omeros Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 26, 2005
First Posted
October 27, 2005
Study Start
October 1, 2004
Primary Completion
March 1, 2010
Study Completion
March 1, 2011
Last Updated
June 27, 2011
Record last verified: 2011-06