Trial | NCT00245271  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    OMS103HP ...

  • Study Participants

    480
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.
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 Started
Oct 31
2004
Primary Completion
Mar 31
2010
Study Completion
Mar 31
2011
Last Update
Jun 27
2011
Estimate

Drug OMS103HP

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

Drug Vehicle

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

1 Experimental

OMS103 Irrigation Solution

2 Placebo Comparator

Balanced Salt Solution (BSS)

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
No Results Posted