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Pharmacokinetic and Safety Study of OMS201 in Subjects Undergoing Ureteroscopic Treatment for Removal of Urinary Tract-Located Stones

NCT00599664 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2010-04-30

No results posted yet for this study

Summary

Evaluate the safety and systemic absorption of OMS201 following exposure during ureteroscopy.

Conditions

  • Urinary Calculi
  • Urinary Stones
  • Urinary Tract Stones

Interventions

DRUG

OMS201

OMS201 irrigation solution during surgery

DRUG

Vehicle

Vehicle irrigation solution during surgery

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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Completion
2008-09-30

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 NCT00599664 on ClinicalTrials.gov