NCT00599664

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

Double-Blind, Placebo-Controlled, Two-Center, Pharmacokinetic Study Evaluating the Systemic Absorption and Safety of OMS201 in Subjects Undergoing Ureteroscopic Treatment of Unilateral Ureteral- or Renal Collecting System-Located Stones

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OMS201 is being developed to facilitate endoscopy of the ureters and to reduce postoperative discomfort, such as pain, frequency, urgency and/or difficult urination following endoscopic surgery to remove a urinary tract stone.

Conditions

• Urinary Calculi
• Urinary Stones
• Urinary Tract Stones

Interventions

Type	Name	Description
DRUG	OMS201	OMS201 irrigation solution during surgery
DRUG	Vehicle	Vehicle irrigation solution during surgery

Timeline

• Start date: 2007-12-01
• Completion: 2008-09-01
• First posted: 2008-01-24
• Last updated: 2010-04-30

Locations

2 sites across 1 country: United States