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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00245271
Other study ID # C04516
Secondary ID
Status Completed
Phase Phase 3
First received October 26, 2005
Last updated June 17, 2011
Start date October 2004
Est. completion date March 2011

Study information

Verified date June 2011
Source Omeros Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 480
Est. completion date March 2011
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 65 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Reconstruction

Intervention

Drug:
OMS103HP
Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours
Vehicle
Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.

Locations

Country Name City State
United States Rush University Chicago Illinois
United States Ohio State University Sports Medicine Columbus Ohio
United States Advanced Orthopedic and Sports Medicine Specialists Denver Colorado
United States Duke University Durham North Carolina
United States Colorado Orthopedic Consultants, PC Englewood Colorado
United States Kerlan-Jobe Orthopaedic Clinic Los Angeles California
United States Temple University Orthopedics Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.) Redwood City California
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Omeros Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The overall incidence of adverse events regardless of relationship to study drug. 90 days Yes
Secondary Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.). 30 days Yes
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