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

NCT00624845 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-06-27

No results posted yet for this study

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

DRUG

OMS103HP

Maximum 6 bags of OMS103HP irrigation solution

DRUG

Vehicle

Maximum of 6 bags of vehicle irrigation solution

Sponsors & Collaborators

  • Omeros Corporation

    lead INDUSTRY

Principal Investigators

  • Scott Houston · Omeros Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624845 on ClinicalTrials.gov