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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00245271

Enrollment

480

Registered

2005-10-27

Start date

2004-10-31

Completion date

2011-03-31

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Knee, Musculoskeletal System, Ligament, ACL reconstruction

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.

Interventions

DRUGOMS103HP

Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours

DRUGVehicle

Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The overall incidence of adverse events regardless of relationship to study drug.	90 days

Secondary

Measure	Time frame
Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.).	30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026