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

NCT00245271 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2011-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Anterior Cruciate Ligament Reconstruction

Interventions

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.

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
17 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2010-03-31
Completion
2011-03-31

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 NCT00245271 on ClinicalTrials.gov