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OpenTrials
Completed

NCT Number: NCT00245271

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

17 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kerlan-Jobe Orthopaedic Clinic, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OMS103HP

Drug

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

Vehicle

Drug

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

Primary outcomes

  1. The overall incidence of adverse events regardless of relationship to study drug.

    Time frame: 90 days

Secondary outcomes

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

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Omeros Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2010
Study completion
2011
First posted
Oct 27, 2005
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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