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

• Sponsor: Omeros Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00245271
• Collaborator: (none)
• Enrollment: 480
• Locations: 10
• Arms: 2
• Duration (Months): 76.9
• Patients Per Site: 48
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Reconstruction	Drug: OMS103HP; Drug: Vehicle	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. The overall incidence of adverse events regardless of relationship to study drug. [90 days]

Secondary Outcome Measures

1. Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.). [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Kerlan-Jobe Orthopaedic Clinic	Los Angeles	California	United States	90045
2	Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)	Redwood City	California	United States	94063
3	Advanced Orthopedic and Sports Medicine Specialists	Denver	Colorado	United States	80230
4	Colorado Orthopedic Consultants, PC	Englewood	Colorado	United States	80110
5	Rush University	Chicago	Illinois	United States	60612
6	Duke University	Durham	North Carolina	United States	27710
7	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
8	Ohio State University Sports Medicine	Columbus	Ohio	United States	43221
9	Temple University Orthopedics	Philadelphia	Pennsylvania	United States	19140
10	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15203

Sponsors and Collaborators

• Omeros Corporation

Investigators

• Study Director: Scott Houston, Omeros Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00245271
• Other Study ID Numbers: C04516
• First Posted: Oct 27, 2005
• Last Update Posted: Jun 27, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Knee; Musculoskeletal System; Ligament; ACL reconstruction

Study Results

No Results Posted as of Jun 27, 2011