Clinical trial NCT00245271: Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Knee
Musculoskeletal System
Ligament
ACL reconstruction
Lead sponsor: Omeros Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-27
Enrollment: 480
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: The overall incidence of adverse events regardless of relationship to study drug.
timeFrame: 90 days
Secondary outcomes:
measure: Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.).
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kerlan-Jobe Orthopaedic Clinic
state: California
city: Redwood City
country: United States
facility: Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
state: California
city: Denver
country: United States
facility: Advanced Orthopedic and Sports Medicine Specialists
state: Colorado
city: Englewood
country: United States
facility: Colorado Orthopedic Consultants, PC
state: Colorado
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Sports Medicine
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Orthopedics
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Omeros Corporation
name: Scott Houston
role: STUDY_DIRECTOR
References: