NCT00624845

Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP With Vehicle Irrigation Solution in Subjects Undergoing Meniscectomy

Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP) compared with vehicle irrigation solution for prevention of pain and pain relief in subjects undergoing meniscectomy. The pain relief is assessed based on Visual Analog Scale (VAS) Pain Scores in the immediate 24-hour postoperative period and for seven days postoperatively.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	OMS103HP	Maximum 6 bags of OMS103HP irrigation solution
DRUG	Vehicle	Maximum of 6 bags of vehicle irrigation solution

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-02-27
• Last updated: 2011-06-27

Locations

8 sites across 1 country: United States