ClinicalTrials.Veeva

Menu

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

O

Omeros

Status and phase

Completed
Phase 3

Conditions

Anterior Cruciate Ligament Reconstruction

Treatments

Drug: Vehicle
Drug: OMS103HP

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

480 estimated patients

Sex

All

Ages

17 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

480 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
OMS103 Irrigation Solution
Treatment:
Drug: OMS103HP
2
Placebo Comparator group
Description:
Balanced Salt Solution (BSS)
Treatment:
Drug: Vehicle

Trial contacts and locations

10

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems